Senior Manager, GMP Quality Operations
About The Position
Sr. Manager, GMP Quality Operations will be the quality contract for quality oversight of GMP operations related to process tech-transfer, scale-up, process validation and manufacture drug substance and Drug product at Stoke’s CMOs. This individual will collaborate and partner closely with CMC department to ensure day-to-day activities maintain compliance with regulations in a phase appropriate manner. This role will report to the Director of Quality and will interface closely with other cross-functional groups such as CMC Manufacturing & Analytical Development, Supply Chain, Regulatory CMC and other functions within Quality. The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working with CMOs and CTLs. It is preferred that this candidate have prior experience working with external vendors and in participating directly and indirectly in regulatory inspections. It is also preferred that this candidate has direct working knowledge of unit operations as it relates to Oligonucleotide Drug Substance manufacturing and process validation. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required.
Requirements
- BS/BA, MS in life sciences or chemistry with a minimum of 8+ years’ experience in Biotech or Pharma setting with direct experience in GMP Operations as it relates to either Oligonucleotide Drug Substance manufacturing, sterile fill finish operations.
- Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and implementing GMPs in a practical manner.
- Experience in managing CMOs.
- Attention to detail with the ability to work within a multi-disciplinary team, as well as with external partners and vendors to establish strong and maintain a strong quality relationship.
- Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
- Experience with drug substance and/or drug product (both preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.
- Ability to work autonomously, provide QA/QC advice, effectively manage time, and deliver results on time.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Nice To Haves
- Experience in process validation for commercial product development.
- Proficient in using Veeva eQMS and Veeva Vault Quality.
- Prior experience in participating in regulatory inspections and responding to regulatory response.
- Ability to manage multiple projects in a fast-paced environment.
- Excellent organizational, interpersonal, verbal, and written communication skills.
- Conflict resolution/management and negotiation skills.
Responsibilities
- Oversee day-to-day management of outsourced GMP operations related to Drug product manufacturing at various CMOs to ensure successful and compliant execution of GMPs to meet regulatory requirements, guidelines, internal policies, and procedures.
- Review and approve documentation generated at CMOs, including master batch records, deviations and investigations, process validation protocols/reports and change controls.
- Perform batch disposition of all GMP batches for release for further manufacturing.
- Compile necessary data and analyze metrics for compliance health checks for External Quality Business Review Meetings and Quality Management Review.
- Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance to ensure product quality, data integrity and patient safety.
- Support internal audit and external GMP vendor audits, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
- Support GMP regulatory inspections as SME, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections.
- Provide GMP compliance technical support during regulatory inspections at Stoke’s CMOs as necessary.
- Drafts and facilitates review and approval of Quality Agreements between CMOs/Suppliers and stoke, as needed
- Contribute to the development of Stoke’s Quality culture.
Benefits
- Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
