Associate Director, Clinical Quality Assurance

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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.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Solid expertise in GCP and ICH clinical requirements, clinical development and methodologies of clinical studies.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective verbal and written communication skills
• Strong organizational skills and the ability to participate effectively cross-functionally.
• Demonstrated ability to lead on-site corporate, external, or Health Authority inspections
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Proficiency in using Veeva and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint).

POSITION:Full-Time, Exempt

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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