Job Description
Job Description
The Quality Assurance Operations (QA Ops) Lead role will involve establishing the Quality structure at the Wilmington Biotech Campus, ensuring the processes conform to our company's policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.
Close collaboration with high performance talent from our company's global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will inspire his/her team to build the future of the company's antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.
Providing training and guidance on the interpretation and implementation of our company's policies and regulatory requirements will also be key priorities for the Director. Throughout the development of the new facility, the successful candidate will focus on commissioning, qualification, and/or validation of the facility, equipment, and process.
POSITION RESPONSIBILITIES
With energy and enthusiasm, the Quality Assurance Operations Lead will:
a) Acting in the role of leading the Quality Assurance Operations team supporting drug substance and drug product manufacturing.
b) Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP, the registered marketing authorization and the associated regulatory requirements.
c) In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site.
d) Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
e) Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
f) Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs.
g) Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
h) Be an advocate of continuous improvement in the Quality Management Systems.
i) Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility.
j) Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release.
k) Drives opportunities for continuous improvement.
l) Provide direct audit support and participate in response team for audits and inspections by Health Authorities.
m) Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
REPORTING STRUCTURE
This position will report into the Site Quality Lead
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
General
This role requires a seasoned Director with a minimum of 15 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
Technical
Must have at least 3 years of operational experience in a regulated environment.
Must have experience in supporting tech transfer or process validation either internally or externally.
Must have 5 years' experience in Antibody Drug Conjugate Process Development and/or Manufacturing.
Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place.
Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
Exceptional analytical, problem solving & root-cause analysis skills.
Ability to multi-task and handle tasks with competing priorities effectively.
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators is preferred.
Strong operations support background ensuring value added and effective quality oversight
Capital Project experience preferred.
People
A great communicator, decisive decision maker and proven ability to deliver excellence
Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends related to Antibody Drug Conjugate Manufacturing.
Experience with new product introductions and/or process qualification/technology transfer
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
Excellent communication skills (written and oral).
Required to work on his/her own initiative in addition to working as part of and leading a team. Must be able to work across a team matrix in order to meet accelerated timelines.
Desire to continuously learn, improve and develop.
Ability to facilitate groups with diverse perspectives, and influence and bring teams to consensus and alignment.
Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed.
Planning and scheduling skills, Proven organizational skills, Flexible approach.
Goal/results orientated, Starter/Finisher.
Education
Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within our company.
Required Skills:
Change Management, Coaching, Decision Making, GMP Compliance, Inspection Readiness, Interpersonal Relationships, Leadership, Leadership Training and Development, Microbiology, Operational Efficiency, Operations Support, People Leadership, Preventive Action, Production Operations, Quality Assurance Processes, Quality Management, Quality Management Standards, Quality Management System Improvement, Quality Risk Management, Regulatory Compliance, Regulatory Requirements, Results-Oriented, Risk Management, Six Sigma, Strategic ThinkingPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$173,200.00 - $272,600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
02/9/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R383639
Job Description
The Quality Assurance Operations (QA Ops) Lead role will involve establishing the Quality structure at the Wilmington Biotech Campus, ensuring the processes conform to our company's policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.
Close collaboration with high performance talent from our company's global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will inspire his/her team to build the future of the company's antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.
Providing training and guidance on the interpretation and implementation of our company's policies and regulatory requirements will also be key priorities for the Director. Throughout the development of the new facility, the successful candidate will focus on commissioning, qualification, and/or validation of the facility, equipment, and process.
POSITION RESPONSIBILITIES
With energy and enthusiasm, the Quality Assurance Operations Lead will:
a) Acting in the role of leading the Quality Assurance Operations team supporting drug substance and drug product manufacturing.
b) Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP, the registered marketing authorization and the associated regulatory requirements.
c) In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site.
d) Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
e) Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
f) Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs.
g) Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
h) Be an advocate of continuous improvement in the Quality Management Systems.
i) Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility.
j) Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release.
k) Drives opportunities for continuous improvement.
l) Provide direct audit support and participate in response team for audits and inspections by Health Authorities.
m) Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
REPORTING STRUCTURE
This position will report into the Site Quality Lead
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
General
This role requires a seasoned Director with a minimum of 15 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
Technical
Must have at least 3 years of operational experience in a regulated environment.
Must have experience in supporting tech transfer or process validation either internally or externally.
Must have 5 years' experience in Antibody Drug Conjugate Process Development and/or Manufacturing.
Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place.
Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
Exceptional analytical, problem solving & root-cause analysis skills.
Ability to multi-task and handle tasks with competing priorities effectively.
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators is preferred.
Strong operations support background ensuring value added and effective quality oversight
Capital Project experience preferred.
People
A great communicator, decisive decision maker and proven ability to deliver excellence
Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends related to Antibody Drug Conjugate Manufacturing.
Experience with new product introductions and/or process qualification/technology transfer
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
Excellent communication skills (written and oral).
Required to work on his/her own initiative in addition to working as part of and leading a team. Must be able to work across a team matrix in order to meet accelerated timelines.
Desire to continuously learn, improve and develop.
Ability to facilitate groups with diverse perspectives, and influence and bring teams to consensus and alignment.
Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed.
Planning and scheduling skills, Proven organizational skills, Flexible approach.
Goal/results orientated, Starter/Finisher.
Education
Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within our company.
Required Skills:
Change Management, Coaching, Decision Making, GMP Compliance, Inspection Readiness, Interpersonal Relationships, Leadership, Leadership Training and Development, Microbiology, Operational Efficiency, Operations Support, People Leadership, Preventive Action, Production Operations, Quality Assurance Processes, Quality Management, Quality Management Standards, Quality Management System Improvement, Quality Risk Management, Regulatory Compliance, Regulatory Requirements, Results-Oriented, Risk Management, Six Sigma, Strategic ThinkingPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$173,200.00 - $272,600.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
02/9/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R383639
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
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