Sr Director of GXP Compliance

Our Immunotherapy client located in Cambridge, MA is growing and looking to add a Sr. Director of GXP Compliance to their team in support of autoimmune and allergic diseases. This exciting role will build and maintain company’s Quality Management Systems (QMS) and will be the leader of the GxP QMS. Will have oversight of GMP, GCP and GLP activities and will be responsible for promoting quality awareness and continuous improvement within the organization. The Director/ Sr Director will be the owner of the strategy to support of the development of the GxP QMS to ensure compliance with applicable GxP regulations, guidances and regulatory agency requirements. 

Responsibilities:
• Provide leadership during the interface with internal and external partners for all GxP matters
• Establish and monitor quality metrics to support the overall health of the QMS, report KPIs and implement continuous improvements
• Perform Quality Management Reviews and Product Quality Reviews
• Leads risk assessment and mitigation activities to establish and improve the QMS, working cross functionally to align the approach to quality and compliance across the organization
• Employ phase appropriate, life cycle management strategies to develop, implement and maintain the GXP QMS
• Directly supports interactions with and responses to Regulatory Agencies on GxP matters, including regulatory inspection support
• Provide input and review for transfer of regulatory obligations
• Demonstrated experience in preparation and review of submissions for regulatory filings
• Demonstrated audit/inspection conduct and management experience. Conducts GXP audits (internal and external). Coordinates the audit program and all related activities
• Write, review and approve SOPs related to GXP activities according to applicable regulations
• Manage the disposition of API, Drug Substance, Drug Product, and Finished Drug Product/Placebo (clinical to commercial)
• Manage clinical material disposition at Packaging and Labeling Contract Manufacturing Sites
• Review manufacturing batch records, CofA’s, deviations, and change controls. • Generating and approving CoA/CoT/CoC
• Lead or support efforts to generate Quality & Technical Agreements with CMOs/vendors
• Establish and maintain GxP Training program and requirements
• Identify Quality and Compliance related issues and collaborate with cross-functional teams to implement practical solutions in a strategic and proactive manner
• Manage validation master plans and oversee all commissioning, qualification, and validation activities, including computer system validation, for phase appropriate GXP compliance
• Lead the implementation, management, and/or coordination of computer system validation (CSV) activities with applicable GxP regulations (e.g., 21 CFR Part 11, Annex 11, and ICH E6R2) and industry standards (e.g., ISPE GAMP 5)
• Oversee method qualifications and validations
• Responsible for trending and managing release and stability data using JMP

Requirements
• Bachelor’s degree in a science discipline (Biology, Chemistry, Biochemistry or similar)
• At least 8-10 years GxP Quality experience in a Pharmaceutical/Biotech setting, including managing the QMS
• Strong knowledge of GXP’s, SOPs and Quality Systems (Deviation, Change Control, CAPA, Risk Assessment etc.)
• Working knowledge of quality systems and regulatory requirements (21CFR part 11, 210/211, E6R2, Q7, Q8, Q9, applicable guidance’s and ICH Guidelines)
• General knowledge of DS and DP manufacturing processes across multiple platforms
• Must be self-motivated and comfortable in a fast-paced, demanding, and dynamic work environment
• Proficiency in JMP is a must

***Role is located in Cambridge, MA and must be able to commute into the office time to time.