Associate Director, Quality Systems

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

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Associate Director, Quality Systems will support the development and maintenance of quality systems for Stoke to ensure compliance with US and international regulations, laws, and guidelines. This person will be accountable for maintaining Stoke’s QMS for product development and clinical trial management. In this role this candidate is required to support change management, audits, and inspections. This person will contribute to maturing and shaping Stoke’s QMS and to meet the various phases of clinical development and product commercialization and life cycle management. The candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This person will report to the Sr. Director of Corporate Quality and will interface closely with other cross-functional groups such as CMC, commercial manufacturing, Regulatory CMC, Regulatory Operations, Regulatory Development, Clinical Operations, Clinical Development, PV, IT and other functions within Quality.

Key Responsibilities:

• As the system owner, responsible for managing and administering Stokes QMS.


• Lead QMS changes and process improvements to increase efficiency, effectiveness, continuous improvement, and maintain compliance with evolving GxP regulations and business needs.


• Apply continuous improvement and operational excellence principles to evaluate, redesign, and mature GxP business processes; define system and data requirements and partner with IT to implement


• Collaborate with IT and system users to facilitate risk assessments for new system releases and manage Change Controls for configuration changes to support system enhancements.


• Own the definition and delivery of quality metrics and reporting, including the underlying data and reporting capability within Veeva to support trending and management review.


• Contributes to maintaining Stoke’s Quality Systems program including necessary procedures, records, manuals, and trend reports for the QMS and other quality systems.


• Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance and ensure data integrity.


• Administer Stoke’s Audit management program for vendor qualification and internal audits.


• Co-manage with Clinical Quality, Stokes Investigator Site and TMF Audit program


• Help train/prepare Stoke GxP employees for regulatory inspections and support GxP regulatory inspections, as necessary.


• Support Stoke’s Quality / Regulatory intelligence process to ensure that current regulations, standards, and industry best practices are maintained.


• Other duties as assigned

Required Skills & Experience:

• BS/BA, MS in life sciences or chemistry


• 10+ years’ progressive experience in Biotech or Pharma setting


• Experience in either developing, implementing and/or managing a QMS or other computerized quality systems


• Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and maintaining an QMS for GxP applications in a practical manner


• Ability to identify areas of improvement and implement practical solutions as it relates to quality management in a virtual environment


• Demonstrated experience in process design and continuous improvement (Lean/Six Sigma or equivalent) applied to quality systems


• Experience managing or leading regulatory inspections (back-room document management)


• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based pragmatic decisions


• Ability to work independently and collaboratively, as required, in a fast-paced start-up environment consisting of internal and external team members


• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines


• Excellent planning, organization and time management skills with the ability to support and prioritize multiple projects

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position currently based in Bedford and will later be based in Waltham.

Travel:

This position will require approximately 5-10 % travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $185,000 - $209,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation. 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).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation. Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

For more information, visit https://www.stoketherapeutics.com/.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.