Senior QC Manager, GMP & Stability

Stoke Therapeutics; Bedford (MA); Hybrid; USD 172,000 - 192,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401K with company match

Unlimited vacation

Job summary

Stoke Therapeutics, a Bedford, MA biotech company, is hiring a Sr. Manager, Quality Control (QC) to oversee GMP testing, stability programs, and analytical method validation across CTLs/CMOs.

You will guide QC strategy, coordinate method transfers, and support regulatory submissions with a focus on patient safety and data integrity. Ideal candidates have 8+ years in biopharma product development, strong GMP knowledge, and leadership experience within cross-functional teams, including regulatory

Qualifications

• Minimum 8+ years in biopharmaceutical product development including analytical method development and transfer to CTLs/CMOs.
• 3+ years in analytical method development/validation for devices including pre-filled syringes.
• Fully versed in GMPs, ICH guidelines, FDA and related regulatory requirements for laboratory functions.
• Experience leading QC activities and supporting regulatory submissions and inspections.

Responsibilities

• Establish and maintain QC SOPs for GMP testing and stability management to meet ICH, FDA, EMA.
• Oversee outsourced GMP release testing at CTLs/CMOs to ensure compliant execution.
• Provide QC oversight for method transfers, qualification and validation.
• Review analytical documentation and CoAs, and ensure data integrity.
• Support product stability programs and regulatory submissions with analytical input.
• Lead audits, CAPA development, and respond to regulatory questions during inspections.
• Collaborate with CMC, QA, and manufacturing teams to ensure quality and timely delivery.

Skills

Quality control

GMP/regulatory knowledge

Analytical data interpretation

Cross-functional collaboration

Autonomous working

Education

B.S. in Biochemistry, Chemistry, Biology, Pharmaceuticals

Advanced Degree (M.S./Ph.D.) in Science

Tools

LIMS

Statistical analysis

Job description

Stoke Therapeutics, a Bedford, MA biotech company, is hiring a Sr. Manager, Quality Control (QC) to oversee GMP testing, stability programs, and analytical method validation across CTLs/CMOs.

You will guide QC strategy, coordinate method transfers, and support regulatory submissions with a focus on patient safety and data integrity. Ideal candidates have 8+ years in biopharma product development, strong GMP knowledge, and leadership experience within cross-functional teams, including regulatory