USA-Quality Assurance Associate II (Clinical)

USA-Quality Assurance Associate II (Clinical)#26-10211 Framingham, MA

All On-site Job Description Description:

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 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 c

GMP/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