OXB is seeking a Senior Specialist in Quality Assurance to oversee operations within an FDA-approved cGMP manufacturing facility in Durham, North Carolina. The ideal candidate will have extensive experience in GMP compliance, documentation review, and cross-functional collaboration to support quality assurance processes
Job Summary
Oversee all Facilities operations within an FDA-approved clinical cGMP manufacturing facility, playing a key part in advancing our mission and making a real difference.
Create, review and approve GMP documentation such as master batch records, SOPs, protocols, reports, master templates, etc.
Competitive total reward packages, wellbeing programs, and career development opportunities are offered.
Matching Summary
Match Score: 85
OXB is seeking a Senior Specialist in Quality Assurance to oversee operations within an FDA-approved cGMP manufacturing facility in Durham, North Carolina. The ideal candidate will have extensive experience in GMP compliance, documentation review, and cross-functional collaboration to support quality assurance processes.
Skills & Requirements
Must-have
cGMP compliance
batch disposition
GMP documentation review
Deviations, Change Controls, and CAPAs
Nice-to-have
quality-focused culture
collaborate across multiple sites
state-of-the-art facilities
Key Requirements
Bachelor’s degree or higher in life sciences discipline
10+ years in a GMP regulated environment
Minimum 7 years of experience in pharmaceutical or biopharmaceutical industry
At least 3 years in Quality
Proven experience managing Change Controls, Deviations, and CAPAs
Strong knowledge of current Good Manufacturing Practices (cGMP)
Strong knowledge of compendial requirements
Experience supporting risk assessments, regulatory inspections and tech transfers