Quality Assurance Specialist - GMP

Our Team:

The R&D Global Quality Organization Genomic Medicine Unit (GQO GMU) team is responsible for external partner management, providing quality oversight of Client-sponsored GMP manufacturing and testing of genomic medicines at third parties. This position will join a collaborative team dedicated to ensuring phase-appropriate manufacturing excellence while maintaining strong partnerships with Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs).

Main responsibilities:

• Support timely review of GMP documentation and ensure alignment with quality and regulatory expectations prior to release and/or approval (batch records, analytical data/specifications, validation protocols/reports, deviations, change controls, CAPAs, etc.).

• Maintain organization of project deliverables for external partner project using applicable tools.

• Identify, communicate, and mitigate quality risks in a pro-active and collaborative manner maintaining the business interests of Client and consideration of suitable outcome for the projects.

• Participate in and support, or lead where appropriate, batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.

• Develop trusting internal team partnerships to ensure highly collaborative project outcomes.

• Develop trusting partnerships with external partners to ensure they understand, respect, and implement Client’s guidance on all Quality matters.

• Contribute to and review in the development of Quality Technical Agreements.

• Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).

• Promote Quality excellence and Quality Culture as a Quality Culture Liaison.

• Lead and/or support the drive for consistency and continuous improvement.

• Make decisions that uphold ethical standards.

• Support site project implementations, as assigned.

Experience:

• Experience in the pharmaceutical industry with a quality focus, including external partner/ CMO management

• Knowledge of Quality Systems and Quality Management programs

• Understanding of cGMP/ICH/FDA/EMA regulations, with background in regulations and guidance for drug substance/ drug product manufacturing and/or gene therapies

• Familiarity with Chemistry Manufacturing Controls (CMC) requirements

• Experience managing quality operations for manufacturing projects

Soft skills:

• Outstanding interpersonal and communication skills, including presentation abilities

• Being a demonstrated team player with experience contributing to multi-disciplinary project teams

• Working effectively with minimal supervision while maintaining strong collaborative relationships

• Strong project management skills and ability to work well under pressure

• Being highly organized with excellent attention to detail

• Managing multiple priorities while maintaining high productivity

• Having the ability to influence across internal and external networks, including Development, Manufacturing, Engineering, Digital, Quality, Regulatory Affairs, and external partners

Technical skills:

• Research & Development activities and processes (specifically in a CMC related field)

• Experience with Gene Therapy/ ATMP processes (preferred)

• Experience with aseptic processing (preferred)

• Proficiency with quality management systems and documentation tools

• Experience with external partner audits and quality assessments

• Knowledge of Quality Technical Agreements

Education:

• B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field

Languages:

• English: Fluent professional practice