Alkermes · 6 hours ago
Dir, Validation
Cincinnati Metro
Full-time
Onsite
Director/Executive
12+ years expAlkermes is a global biopharmaceutical company that develops medicines for complex psychiatric and neurological disorders. The Director of Validation will lead all validation activities, ensuring compliance with regulatory guidelines and overseeing the corporate validation program, while managing both internal and contractual employees.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
Benefits
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
Received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023)
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
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2026-01-16
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