Senior Specialist, Quality Assurance

oxfordbiom•Durham, NC

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Quality Assurance Senior Specialist to join our Quality. In this role, you will be responsible for overseeing all Facilities operations within an FDA-approved clinical cGMP manufacturing facility, playing a key part in advancing our mission and making a real difference.

Requirements

Bachelor’s degree or higher in life sciences discipline. 10+ years in a GMP regulated environment may be substituted in lieu of degree.
Minimum 7 years of experience in the pharmaceutical or biopharmaceutical industry, including 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.
Demonstrated ability to drive a quality-focused culture, build effective processes, and collaborate across multiple sites and stakeholders in a fast-paced environment.
Experience supporting risk assessments, regulatory inspections and tech transfers.

Responsibilities

Act as subject matter expert for cGMP compliance, operations and disposition.
Oversee manufacturing activities within the production suites to support potential quality/compliance events, provide guidance on documentation comments and ensure compliance with applicable procedures.
Provide manufacturing and floor support for critical operations, including but not limited to vial thaw, transfection and fill/finish.
Review and approve executed GMP documentation such as batch records, logbooks, protocols and forms.
Own the end-to-end batch disposition deliverables to meet client expectations.
Create, review and approve GMP documentation such as master batch records, SOPs, protocols, reports, master templates, etc.
Collaborate cross-functionally to support QA Raw Materials, Quality Systems, Technical Quality and Quality Control.
Author, review and approve Deviations, Change Controls, and CAPAs.
Review and approve alarm reports and disruption to controlled environment documentation.
Oversee material shipments and quality hold of materials.
Participate in site risk assessments.
Perform area and process walkthroughs within Manufacturing, Warehouse, Quality Control and Utility areas.
Ensure compliance with applicable procedures and production requirements. Perform follow-up on potential non-compliances and escalate to management as necessary.
Support phase appropriate technology transfers as a quality expert.
Support preparation, participation, and follow-up for regulatory inspections, internal audits, and client audits.