Location: Boston, MA (Hybrid)
Science: Small Molecule Therapeutics
Job Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.
Primary Job Responsibilities:
- Lead quality assurance for CMO-related activities, overseeing GMP compliance for manufacturing, testing, and release processes along with batch reviews and tech transfers.
- Drives collaboration between internal CMC teams and external partners, aligning quality goals from clinical to commercial phases, and ensures the implementation of compliant and effective quality practices.
- Prepares for quality audits and inspections by managing quality documentation and leading discussions in meetings to maintain product excellence and compliance.
- Promotes a culture of quality within the organization, sets strategic objectives, manages the quality budget, and oversees personnel development and global compliance initiatives.
Primary Job Requirements:
- Bachelor's in life sciences with 12+ years in GMP quality leadership, expertise bringing pharmaceutical products through clinical stage into production, and experience in external manufacturing model are required.
- Well-versed in global GxP standards, capable of managing fast-paced environments, and skilled in navigating health authority expectations.
- Excels in leading teams and projects, demonstrating a successful track record with suppliers and CMOs, underpinned by in-depth knowledge from drug development to market.
- Champions continuous quality improvement, adept at working independently, setting priorities, and driving team excellence through effective management and communication.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
