Stoke Therapeutics · 22 hours ago
Senior Manager, GMP Quality Operations
Bedford, Massachusetts, United States
Full-time
Hybrid
Senior Level, Lead/Staff
$171K/yr - $198K/yr
8+ years expStoke Therapeutics is a biotechnology company focused on restoring protein expression through RNA medicine. The Senior Manager, GMP Quality Operations will oversee quality compliance for GMP operations related to drug manufacturing, ensuring adherence to regulatory requirements and collaborating closely with various departments to maintain product quality and patient safety.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
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
Participation in our Employee Stock Purchase Program (ESPP)
Company
Stoke Therapeutics
Stoke is developing antisense oligonucleotide medicines that target RNA splicing to increase gene expression for treatment.
51-200 employees
H1B Sponsorship
Stoke Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$360.1MKey Investors
Apple Tree Partners,RTW InvestmentsApple Tree Partners
2024-03-27Post Ipo Equity· $125M
2020-11-24Post Ipo Equity· $105.1M
2019-06-19IPO
Leadership Team
Edward Kaye
CEO & Founder
Adrian Krainer
Co-founder & Director
Recent News
2026-02-05
BioWorld Financial Watch
2026-01-15
2026-01-13
Company data provided by crunchbase