About the Role
Senior Director R&D and Clinical Quality Assurance (CQA) is responsible for providing leadership, strategic vision, and efficient execution in managing compliance related to Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), Good Pharmacovigilance Practices (GPVP’s) and other related activities to deliver on the client’s clinical goals.
The successful candidate will be a charismatic leader with strong critical and strategic thinking skill to establish and oversee R&D, Preclinical, Clinical and Pharmacovigilance QA activities associated with cell and gene therapy products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and gene modified hematopoietic stem cells including technology platforms for ZFP genome editing, Adeno-associated Virus (AAV) gene therapy and autologous & allogeneic CAR-Tregs.
This is an exciting opportunity for someone who has the expertise to successfully lead this function and partner with Clinical Development and Clinical Operations, R&D and Pharmacovigilance organizations globally to provide strategic GCP, GLP and GPVP compliance oversight. Effective communication and collaboration with internal and external stakeholders are a key requisite in this position.
The ideal candidate for this position will have demonstrated in-depth experience of establishing and managing R&D and CQA functions in compliance with GCP, GLP, and GPVP applicable regulations.
Master’s degree or equivalent in a science or health care field and significant experience in an FDA-regulated environment. Minimum of 15 years of experience in the pharmaceutical industry with a GCP focus, ideally covering all clinical phases through commercial drug product, with at least 5 years in a GCP quality/compliance role.
Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GLP, and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations.
Experience conducting quality audits of CROs and Investigational sites.
Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust-building behaviors in all dealings are essential and required.
In-depth knowledge of FDA and ICH regulatory requirements. Experience with EMA and WHO regulations a plus.
Demonstrates initiative and proactively provides collaborative support to the clinical team as a credible communicator. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks.
Continuously demonstrates a positive, ‘can do’ and service-oriented attitude.
Excellent interpersonal, verbal and written communication skills with commitment to accuracy. Ability to communicate and work independently with scientific/technical personnel.
Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Self-motivated, detail-oriented and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
This position requires travel up to 25%.