Manager, GCLP Compliance

Role Summary

The Manager, GCLP Compliance oversees all aspects of GCLP testing compliance for Stoke’s clinical development programs with CRO partners. They contribute to growing Stoke’s GCLP quality monitoring program, support DMPK study data quality and regulatory compliance, and help establish and maintain the Quality Management System for GCP and GCLP. They partner with Quality, DMPK and clinical study teams to foster a quality culture and maintain inspection readiness.

Responsibilities

• Contribute to the development of procedures to oversee the quality component of Stoke‚Äôs GCLP/Bioanalytical work at vendors.
• Provide support with vendor qualification and management.
• Partner with DMPK and Clinical Development Operations to support compliant execution of GCLP bioanalytical work to meet regulatory requirements, guidelines, internal policies, and procedures.
• Collaborate with 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 and coordinate CAPAs with SMEs as applicable.
• Support investigations into GCLP non-compliance; analyze findings with CROs and study teams; ensure documentation, CAPAs, and timely regulatory reporting as needed.
• Represent QA on project teams, provide GCLP interpretation, training, and supportive services to maintain and improve research quality for regulatory submissions.
• Help train/prepare Stoke employees for regulatory inspections.
• Provide input to and review responses to regulatory agency questions resulting from inspections.
• Contribute to the development of Stoke‚Äôs Quality culture.

Qualifications

• Required: BS in Biochemistry, Chemistry, Biology, Pharmaceuticals or equivalent; minimum 6+ years in a GCP/GLP environment supporting biopharmaceutical development.
• Required: Experience with CROs and vendors; strong knowledge of GCP/GCLP, ICH guidelines, FDA and EU regulatory requirements (experience with other countries is a plus).
• Preferred: Experience with RNA-based therapeutic modalities.
• Required: Experience building systems from scratch and scaling processes; practical knowledge of GCLP audits and business standards.
• Required: Detail-oriented with ability to work in a cross-functional team and with external partners to maintain quality relationships.
• Required: Ability to make regulatory-driven decisions, work autonomously, manage time, and deliver results; strong communication and negotiation skills.

Skills

• Strong verbal and written communication
• Auditing and issue investigation
• Risk-based quality management
• Regulatory inspection readiness
• Cross-functional collaboration

Education

• BS in Biochemistry, Chemistry, Biology, Pharmaceuticals or equivalent

Additional Requirements

• Travel: Approximately 20% travel