Site Quality Head, Quality Director
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Site Quality Head to lead quality assurance and regulatory compliance for an oral solid dose CDMO facility in High Point, North Carolina. The role involves establishing quality strategy, ensuring global regulatory adherence, and directing pharmaceutical quality systems across manufacturing operations.
Responsibilities
- Establish and execute site quality strategy aligned with regulatory requirements and business objectives
- Serve as independent quality authority on Site Leadership Team with final batch disposition authority
- Oversee granulation, compression, coating, dissolution testing, and stability program oversight
- Direct cleaning validation, process validation, and data integrity governance across operations
- Lead site quality organization development and manage regulatory authority interfaces
Requirements
- Bachelor's or advanced degree in Life Sciences, Engineering, or Pharmaceutical Sciences
- 12-15 years pharmaceutical manufacturing experience with significant quality leadership roles
- Strong knowledge of oral solid dose manufacturing processes and controls
- Expertise in FDA 21 CFR Parts 210/211, EU GMP, and ICH guidelines
- Experience with pharmaceutical quality systems and risk management frameworks
- Proven ability to lead regulatory inspections and manage compliance programs
Vacancy posted 5 days ago
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