Quality Assurance Director, Clinical (Contractor/Temp)

2 days ago

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Caribou Biosciences

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Clinical-stage biopharmaceutical company developing transformative therapies to treat devastating human diseases

Next-generation CRISPR genome editing • allogeneic CAR-T cell therapies • iPSC-derived NK cell therapies • oncology

51 - 200

💰 $125M Post-IPO Equity on 2023-07

Description

• Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. • The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. • The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company’s functional areas. The candidate will perform audits of service providers, study sites, and internal processes. • The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. • In addition, the candidate must actively manage an appropriate level of inspection readiness of Company’s clinical stakeholders and act as a catalyst for continuous process improvement.

Requirements

• Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred. • Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research. • Proven track record in developing and implementing quality systems and processes in a clinical setting. • Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits. • Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards. • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance. • The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills. • Conscientiously detail-oriented and organized, impeccable attention to data review. • Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways. • Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. • Detail-oriented mindset with a proactive approach to problem-solving and decision-making. • Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.