Senior Specialist, Quality Assurance

About the role

We are seeking a Quality Assurance Senior Specialist to oversee Facilities operations within our FDA-approved clinical cGMP manufacturing facility. This role plays a crucial part in advancing our mission to enable life-changing therapies to reach patients worldwide.

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 vial thaw, transfection, and fill/finish.
• Review and approve executed GMP documentation such as batch records, logbooks, protocols, and forms.
• 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.
• Own the end-to-end batch disposition deliverables to meet client expectations.
• 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.

Requirements

• Bachelor’s degree or higher in life sciences discipline.
• 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.

Qualifications

• 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.

Skills

• Strong knowledge of current Good Manufacturing Practices (cGMP).
• Strong knowledge of compendial requirements.
• Proven experience managing Change Controls, Deviations, and CAPAs.
• 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.

Benefits

Competitive total reward packages, wellbeing programs, career development opportunities, supportive, inclusive, and collaborative culture, state-of-the-art labs and manufacturing facilities, and a future-focused and growing fast company.

Pay

TBD

Schedule

TBD

Company

OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV), adenovirus and other viral vector types. OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines. OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US.