Director, Validation

Overview

Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, computer systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.

Responsibilities

• Development and oversight of corporate validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement.
• Responsible for preparation and management of corporate validation budget which includes clinical and commercial operations support and capital projects.
• Mentoring and developing staff which entails selecting and grooming department management team. Also, provide continuous assessment of team and implementation of various training programs to mitigate department weakness with respect to technical and compliance topics.
• Participate on various Alkermes quality and technical teams.
• Participate in corporate Capital Project Review Team and act as Quality representative.
• Develop and utilize department metrics as a tool for continuous improvement.
• Clearly define departmental roles and responsibilities with respect to internal and external boundaries.
• Provide annual reviews for departmental management team which includes establishment of individual goals and objectives.
• Review and approve departmental purchase requisitions.
• Translate corporate vision and goals into departmental goals and initiatives and provide oversight for success. Collaboration on site goals and policy creation along with assurance that tactical implementation of goals and policies are adhered to.
• Anticipate, analyze, and resolve issues within local Quality department as well as interdepartmentally. Create conditions and emphasize inclusion of all involved departments as necessary.

Qualifications

• Bachelor’s Degree in relatable field required.
• 12+ years’ experience in cGMP pharmaceutical manufacturing environment.
• Supervisory Experience: minimum of 6 years.
• Working knowledge of Quality Systems.
• Detailed knowledge of all aspects of validation.
• Detailed working knowledge of GMPs, FDA Aseptic Processing Guideline, EU “Orange Book”, GAMP, and ICH guidelines.
• Experience and understanding of complex projects and ability to make key decisions based on corporate drivers (best interest of the company).
• Work with cross-functional leadership to provide resolutions to technical and/or personnel issues within projects and report issues to senior management and partners when they will have an impact on budget and/or timeline.
• Communication skills – must be able to effectively communicate department vision to staff members. Also, must be able to communicate laterally within the quality unit and externally.
• Solid organization and problem-solving skills.
• Strong leadership ability.
• Must be able to provide independent assessment of department with respect to performance.

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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.