Associate Director, Clinical Quality Compliance

Stoke Therapeutics•Bedford, MA

7d•$192,000 - $215,000•Hybrid

About The Position

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This role will report into The VP of Quality and will interface closely with other cross-functional groups such as Clinical Development, Clinical Development Operations, DMPK, Regulatory and other functions within Quality. This person will support Stoke’s clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all Stoke clinical and bioanalytical studies. This person will be responsible for establishing Stokes inspections management program for GCP inspections and expected to be influential towards maturing Stoke’s quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute Stoke’s Clinical Quality Management Plan for compliance and risk monitoring for all Stoke clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Requirements

BS/BA, MS or PhD and a minimum of 8+ years’ experience, respectively, in Biotech, Pharma or CRO.
Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
Ability to work autonomously, effectively manage time and deliver results on time.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Conflict resolution/management and negotiation skills.
Ability to manage multiple projects in a fast-paced environment.
Excellent organizational, interpersonal, verbal, and written communication skills.

Responsibilities

Contribute to the development and maintenance of procedures for Stoke’s GCP/ GCLP managed activities.
Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
Participate in the development of GCP/GLP auditing strategies.
Lead internal/external/Investigator site/TMF audits, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
Establish Stoke’s GCP inspection preparation program and facilitate mock PAI inspections as necessary.
Co-Host GCP BIMO/Health Authority inspections, as necessary, and provide input to responses to regulatory agency findings and questions.
Contribute to the development of Stoke’s Quality culture.