Senior Manager, GCLP Compliance na Stoke Therapeutics

Position Purpose:

The Sr. Manager, GCLP Compliance, is responsible for overseeing all aspects of compliance for GCLP testing for Stoke’s clinical development programs with Stoke’s Contract Research Organizations (CROs) partners. This person will be a key contributor in growing and shaping Stoke’s GCLP quality monitoring program and will be responsible for supporting Stoke’s DMPK study team towards ensuring data quality and compliance with regulations (e.g., FDA, EMA, etc.). This candidate will be required to contribute to the establishment and maintenance of Stoke’s Quality Management System for the areas of GCP and GCLP. This person will partner with Stoke’s Quality, DMPK and clinical study teams to create a quality culture within Stoke and help reach a sustained state of inspection readiness.

This role requires the person to identify and effectively communicate compliance risks and drive action plans to mitigate risks. This role will report into the Director of Clinical Quality and will interface closely with other cross-functional groups such as DMPK, Clinical Development, Clinical Operations, Regulatory and other functions with our vendors and across the Stoke organization.

The ideal candidate will have a strong working knowledge of relevant GCP/GCLP FDA, EU, ICH guidelines, and regulations and experience working with CROs and vendors. This candidate should have experience in auditing and a demonstrated ability to communicate significant observations in a sound and factual manner. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to roll up their sleeves and directly contribute to the implementation of processes and resolution of issues as required.

Key Responsibilities:

• Contribute to the development of procedures to oversee the quality component of Stoke’s GCLP/ Bioanalytical work at the vendors.
• Provide support with vendor qualification and management.
• Partner closely with members of the DMPK and Clinical Development Operations teams to support the successful and compliant execution of GCLP bioanalytical work to meet regulatory requirements, guidelines, internal policies, and procedures.
• Collaborate with Subject Matter Expert’s (SMEs) to develop, maintain and report on metrics from quality monitoring plans.
• Support internal, in-process, study, and process audits related to GCLP activities and bioanalytical studies.
• Oversee and assist with audits of vendors for GCLP Bioanalytical laboratories, as necessary, and work with Stoke’ technical SMEs staff to ensure the implementation of appropriate CAPAs as applicable.
• Support investigations into GCLP non-compliance. Partner with CROs and the DMPK and 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.
• Represent QA on project teams, as needed and provide GCLP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Help train/prepare Stoke employees for regulatory inspections.
• Provide input to and review of responses to regulatory agency questions resulting from regulatory inspections.
• Contribute to the development of Stoke’s Quality culture.

Required Skills & Experience:

• S. in Biochemistry, Chemistry, Biology, Pharmaceuticals or equivalent with a minimum of 10+ years’ combined experience in a GCP/GLP environment supporting the development of biopharmaceutical products.
• Experience in RNA based therapeutic modalities preferred.
• Fully versed in GCP/GLP, ICH Guidelines, FDA, and European regulatory agency requirements (understanding of other regulatory guidelines for other countries a plus).

• Experience building systems from scratch and scaling processes.
• Practical knowledge of GCLP related to audits and business standards.
• Attention to detail with the ability to work within a multi-disciplinary team, as well as with external partners and vendors to establish and maintain a strong quality relationship.
• Ability to make decisions that are guided by applicable regulatory mandates, Stoke and designated vendor policies, procedures, and business plans.
• Ability to work autonomously, provide QA advice, effectively manage time, and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Strong verbal and written communication skills.
• Conflict resolution/management and negotiation skills.

Location(s):

Stoke is located in Bedford, MA.  This position is a hybrid position with an office setting based in Bedford, MA location.

Travel:

This position will require approximately 20% travel.