Quality Engineering Lead
Bright Horizons UK
Director, GMP Quality Assurance
Disc Medicine
full-time
Posted on:
Location Type: Hybrid
Location: Watertown • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Provide quality partnership and oversight of Disc Medicine’s Biologics manufacturing, testing, and disposition of products.
- Support ongoing technology transfer of drug product and device manufacturing processes.
- Ensure compliance in Disc Medicine Quality Management System and CDMO manufacturing and testing operations with applicable GMP regulations.
- Collaborate with cross-functional teams to draft, review, and verify documents to Health Authority CMC submissions.
- Develop, implement and approve risk-based quality system oversight related to CDMO manufacturing and testing of combination products.
- Partner closely with internal stakeholders to ensure program alignment and timely delivery of quality milestones.
- Identify and escalate quality risks while driving effective, compliant resolutions.
Requirements
- Bachelor’s Degree in a scientific discipline or related scientific field.
- 12-15 years of progressive Quality Assurance experience, with experience in Technology Transfer, Global Quality Management System design and implementation.
- Hands-on expertise with Combination Products (Device and Biologic) including the ability to develop business and QMS processes, procedures.
- Proven track record for building Quality culture with direct experience in supporting GMP operations.
- Proven track record for working on CMC, development program, quality management review, and vendor joint steering committees.
- Demonstrated experience in all aspects of clinical development of biologics is desirable; development of quality strategy and direct discussions with applicable Health Authorities.
- Self-driven, extraordinarily organized, and have an established track record for building effective working relationships across stakeholder groups.
- Ability to convey complex issues, risks, solutions, and decisions succinctly.
- Ability to travel nationally and internationally (10-20%)
Benefits
- Comprehensive benefits
- Competitive compensation packages
- Flexible work environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceTechnology TransferGlobal Quality Management SystemCombination ProductsGMP operationsCMCclinical development of biologicsquality strategyrisk-based quality system oversightdocument drafting and review
Soft skills
self-drivenorganizedeffective working relationshipscommunicationproblem-solvingcollaborationstakeholder managementquality culture buildingrisk identificationresolution driving
