Quality Systems Lead, Biotech (QMS, GMP)

Stoke Therapeutics; Bedford (MA); Hybrid; USD 185,000 - 209,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life, disability insurance

401K with company match

Unlimited vacation time

Tuition assistance

Employee Stock Purchase Program (ESPP)

Job summary

Stoke Therapeutics is seeking an Associate Director of Quality Systems to lead the QMS, drive regulatory readiness, and partner with IT for system improvements. The role demands 10+ years of biotech/pharma experience, strong GMP knowledge, and a track record in audits and inspections.

The role is hybrid in Bedford, MA, with a move to Waltham, MA, and offers a comprehensive benefits package including bonus and equity participation.

Qualifications

• BS/BA or MS in life sciences or chemistry required.
• 10+ years in Biotech/Pharma with QMS experience.
• Experience developing or managing a QMS.
• Strong knowledge of FDA, EU, ICH GMP regulations.
• Ability to implement quality improvements in a virtual environment.
• Experience handling regulatory inspections.
• Proven ability to design process improvements and drive compliance.

Responsibilities

• Manage and administer Stoke's QMS.
• Lead QMS changes and process improvements to ensure compliance.
• Define and mature GxP business processes; partner with IT on system requirements.
• Collaborate with IT to assess risks for releases and manage Change Controls.
• Own quality metrics and reporting, including Veeva-based data.
• Maintain Stoke’s Quality Systems program including procedures and trend reports.
• Provide GMP compliance interpretation and regulatory support.
• Administer Audit management for vendor qualification and internal audits.
• Co-manage with Clinical Quality on Investigator Site and TMF Audit programs.
• Train Stoke GxP employees for regulatory inspections and support inspections.
• Support regulatory intelligence to stay aligned with current regs.
• Other duties as assigned.

Skills

QMS ownership

GxP compliance

Regulatory inspections

Lean Six Sigma

Cross-functional collaboration

Risk-based decision making

Analytical thinking

Project management

Education

BS/BA, MS in life sciences or chemistry

Tools

Veeva

Job description

Stoke Therapeutics is seeking an Associate Director of Quality Systems to lead the QMS, drive regulatory readiness, and partner with IT for system improvements. The role demands 10+ years of biotech/pharma experience, strong GMP knowledge, and a track record in audits and inspections.

The role is hybrid in Bedford, MA, with a move to Waltham, MA, and offers a comprehensive benefits package including bonus and equity participation.