Associate Director, Quality Systems

Stoke Therapeutics•Bedford, MA

10d•$185,000 - $209,000•Hybrid

About The Position

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.

Requirements

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

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