Job Description
Responsibilities
POSITION SUMMARY Provide a brief description of the general nature of the position; an overview of the purpose and objective of this position and reporting relationships. (Why does this job exist) Management of Quality Assurance Operations functions across the Wilmington, Ohio site. Ensure that the site operates in compliance with FDA, EU and all other regulations as required, and remains inspection ready at all times. |
MAJOR RESPONSIBILITIES
| Major Responsibility | Percentage of time spent on each responsibility |
| List the primary job duties for the role | Estimate a percentage of time spent on each activity (Must add to 100%) |
| 25 |
| 25 |
| 25 |
| 25 |
QUALIFICATIONS
- Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with little supervision required; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
- Good communication skills (written and verbal) at all levels of the organization.
- A leader of people who uses influence, coaching skills, collaboration and persuasion to accomplish objectives in a cross-functional team environment.
- Experience with FDA regulated pharmaceutical manufacturing site
- A thorough working knowledge of regulatory compliance, process validation, technology transfer, plant engineering and competent software skills.
- Able to grasp complex technical issues and make appropriate compliant decisions based on data and information from various sources.
- Expert knowledge of Quality Operations in a pharmaceutical manufacturing environment.
- Parenteral and solid oral dosage experience is essential.
- Experience in developing and implementing a CGMP compliance program in association with bringing a product through clinical trials to commercialization.
- Contribute to the continuous improvement of site and company Quality Management Systems and processes through participation in the Extended Quality Leadership Team.
EDUCATION AND EXPERIENCE
- Minimum education Bachelor of Science degree
- 15+ years experience in the Pharmaceutical Industry with progressive Quality leadership responsibilities. .
- Significant managerial role in Quality (at least 5 years).
WORKING CONDITIONS
This position is expected to be flexible in work hours to meet the business needs, is an on site role and may require occasional travel .
PHYSICAL REQUIREMENTS
There are no special, physical requirements for this position.
#LI-RS1
#Onsite
About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Responsibilities
POSITION SUMMARY Provide a brief description of the general nature of the position; an overview of the purpose and objective of this position and reporting relationships. (Why does this job exist) Management of Quality Assurance Operations functions across the Wilmington, Ohio site. Ensure that the site operates in compliance with FDA, EU and all other regulations as required, and remains inspection ready at all times. |
MAJOR RESPONSIBILITIES
| Major Responsibility | Percentage of time spent on each responsibility |
| List the primary job duties for the role | Estimate a percentage of time spent on each activity (Must add to 100%) |
| 25 |
| 25 |
| 25 |
| 25 |
QUALIFICATIONS
- Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with little supervision required; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
- Good communication skills (written and verbal) at all levels of the organization.
- A leader of people who uses influence, coaching skills, collaboration and persuasion to accomplish objectives in a cross-functional team environment.
- Experience with FDA regulated pharmaceutical manufacturing site
- A thorough working knowledge of regulatory compliance, process validation, technology transfer, plant engineering and competent software skills.
- Able to grasp complex technical issues and make appropriate compliant decisions based on data and information from various sources.
- Expert knowledge of Quality Operations in a pharmaceutical manufacturing environment.
- Parenteral and solid oral dosage experience is essential.
- Experience in developing and implementing a CGMP compliance program in association with bringing a product through clinical trials to commercialization.
- Contribute to the continuous improvement of site and company Quality Management Systems and processes through participation in the Extended Quality Leadership Team.
EDUCATION AND EXPERIENCE
- Minimum education Bachelor of Science degree
- 15+ years experience in the Pharmaceutical Industry with progressive Quality leadership responsibilities. .
- Significant managerial role in Quality (at least 5 years).
WORKING CONDITIONS
This position is expected to be flexible in work hours to meet the business needs, is an on site role and may require occasional travel .
PHYSICAL REQUIREMENTS
There are no special, physical requirements for this position.
#LI-RS1
#Onsite
About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
About Alkermes, Inc.
At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. With our portfolio of marketed medicines and investigational pipeline candidates, we seek to make a meaningful difference in the way people manage their diseases. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.
Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.
Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Related Jobs
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
Enhance the ALDI customer shopping experience in a collaborative team environment as an ALDI Cashier or Stocker. As a member of our team, you'll be operating the registers or other machinery, stocking...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
Enhance the ALDI customer shopping experience in a collaborative team environment as an ALDI Cashier or Stocker. As a member of our team, you'll be operating the registers or other machinery, stocking...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
Enhance the ALDI customer shopping experience in a collaborative team environment as an ALDI Cashier or Stocker. As a member of our team, you'll be operating the registers or other machinery, stocking...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
Enhance the ALDI customer shopping experience in a collaborative team environment as an ALDI Cashier or Stocker. As a member of our team, you'll be operating the registers or other machinery, stocking...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
As a Store Manager Trainee, you'll train on all aspects of successfully running a store in preparation for running for your own store. You'll be involved in supervising day-to-day store activities, en...
Enhance the ALDI customer shopping experience in a collaborative team environment as an ALDI Cashier or Stocker. As a member of our team, you'll be operating the registers or other machinery, stocking...
Alkermes, Inc. would like you to finish the application on their website.
