Sr Director

Job Description

Director/Sr Director of GXP Compliance

About Us

Anokion SA is a clinical-stage biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease. For more information, visit

Job Summary

The Director/Sr Director of GXP Compliance will build and maintain Anokion’s Quality Management Systems (QMS) and will be the leader of the GxP QMS. The person will be responsible for 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. The Director/Sr Director should possess the following attributes:

• Thorough knowledge of all facets of Quality Assurance (GxP) and Quality Systems to assure subject safety, data integrity, product quality (SISPQ) and operational compliance
• Proven skills and track record of building and scaling Quality function within the pharmaceutical or biotechnology industry
• Track record of managing Quality operations in the small and agile company setting
• Strong organizational, decision-making and time management skills to lead effectively in a fast-paced and innovative company
• Provide leadership, guidance and coaching to maintain an engaged and productive team
• Demonstrated project management experience and skills, with the ability to coordinate multiple projects

This position will report to the Chief Medical Officer and the company is based in Cambridge MA. This role can be remote with travel to Cambridge, MA as needed/dictated by business necessity.

Responsibilities and Duties

• 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

Qualifications

• 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 guidances and ICH Guidelines)
• General knowledge of DS and DP manufacturing processes across multiple platforms
• Excellent interpersonal, verbal, and written communication skills
• Must be self-motivated and comfortable in a fast-paced, demanding, and dynamic work environment
• Proficient in MS Word, Excel, Power point and other MS applications
• Proficiency in JMP is a must