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About the role
- Director of Clinical Quality in a biopharmaceutical company developing cell therapies. Leading GCP/GLP compliance and clinical oversight for development programs in the US and internationally.
Responsibilities
- Establish and lead GCP/GLP/GPV efforts
- Have clinical quality compliance oversight for clinical development programs both in the US and internationally
- Collaborate with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs
- Develop the risk-based audit and compliance strategy for all programs
- Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, GLP, and Company policies and procedures
- Assess impact of audit findings on subject safety, data integrity, and business operations
- Support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions
Requirements
- Bachelor’s degree in a scientific discipline is required
- Advanced degree in life sciences, pharmacy, or a related field preferred
- 12+ years of experience in GCP/GLP compliance and monitoring within the biotechnology or pharmaceutical industry, with a focus on autologous and allogeneic cell therapy treatments preferred.
- Strong knowledge of applicable regulatory requirements, including FDA and EMA regulations and ICH guidelines, with an emphasis on requirements associated with the study of ATMPs, particularly genetically modified cells as therapies.
- Proven track record in maturing/managing phase-appropriate, risk-based clinical QMS (e.g. ICH E6 (R3), QbD) and processes in a clinical setting.
- Successful management of audits and inspections by regulatory agencies.
- Excellent verbal, written and presentation skills to effectively communicate with all levels of management.
- Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix, cross-functional environment.
- Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
- Strong clinical business acumen skill, with a focus on risk management and continuous improvement.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering commitments.
Benefits
- Annual bonus
- Comprehensive benefits
- Participation in the Company’s stock option plan
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