Associate Director, Clinical Quality Assurance

COMPANY

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

SUMMARY:

Associate Director, Clinical Quality Assurance  

The Associate Director, Clinical Quality Assurance (CQA), will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Centessa sponsored clinical trials (Early-Late Phase) with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Centessa Standard Operating Procedures (SOPs), and current industry standards and practices. 

The Associate Director, CQA will lead and perform day-to-day clinical quality operations and compliance activities to support the success of our Centessa clinical programs. You will maintain and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness regarding all quality requirements, and regulatory standards. 

Responsibilities: 

• Establish and maintain GCP QA programs, policies and procedures. 
• Facilitate the compliance of ongoing clinical programs with applicable health authority regulations and guidelines. 
• Act as the primary GCP QA subject matter expert and point of contact for all GCP related matters and issues.
• Work collaboratively with the Clinical Development Operations to ensure compliance standards are achieved.
• Identify and assess compliance risk and develop and work collaboratively to implement risk mitigation measures as required.
• Support GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.
• Collaborate with Clinical and all related functions to develop, review and approve related procedures, forms and templates.
• Ensure the implementation and maintenance of detailed audit plans and audit schedules.
• Prepare KPIs and metrics, present status updates as needed.
• Ensure the timely and effective investigation and follow up of all identified or assigned quality issues. Conduct root cause analysis for recurring issues.
• Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.
• Work collaboratively with impacted functions to assess clinical trial material temperature excursions and conduct product complaint investigations.
• Conduct or arrange for audits, as needed, and prepare written audit reports; communicate findings and recommendations and evaluate the adequacy and completeness of responses and CAPA plans.
• Work closely with Clinical Development, Clinical Development Operations, and other functions/departments to ensure a continued state of compliance readiness.
• Serve as the CQA representative for assigned study teams.
• Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agency inspections.
• Provide management reports on audit strategy, plans, and findings.
• Support process improvement initiatives; lead continuous improvement projects within Quality.
• Maintain knowledge of GCP regulations, guidelines, company standards and procedures.  

Requirements: 

• Minimum Bachelor of Science Degree in Biology, Chemistry, or equivalent
• 8-10 years relevant work experience in the Biotechnology/Pharmaceutical industry.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Hands-on experience in drug life cycle management.
• A successful track record of work