- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as Senior Director, Global Clinical Quality.
- You will work with the Clinical Research, Product Development and Quality teams in supporting our efforts in this exciting new area of cancer immunotherapy.
- This individual will work cross functionally to develop and be responsible for our quality systems and processes to meet all US, European and global Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance (GVP) requirements. This position will report directly to the company quality head.
Responsibilities (include but are not limited to):
Responsible for our company GCP, GLP and GVP quality and compliance program globally, covering all applicable areas of Clinical research, including, Medical, Laboratory and Pharmacovigilance areas:
- GCP, GLP and GVP Quality System Development and Management:
- Develop and implement GCP and GLP quality systems for our company that follow International Congress of Harmonization (ICH) guidance, FDA, EMA and global competent authority regulations and other relevant guidance
- Provide periodic reports to company management on the quality and compliance status of the company quality system and Clinical Research teams.
- Provide periodic reports on the compliance status of all outside CRO, testing and animal labs and treatment centers
- Internal Audit Management:
- Prepare and implement audit plans for all CROs, testing and animal laboratories, internal company departments, and clinical treatment centers
- Manage audit system and follow up on corrective action and CAPA to complete audit certifications
- Regulatory Inspection Preparation and Management:
- Ensure inspection readiness of all internal and external entities in preparation of competent authority inspections
- Lead, develop and implement regulatory inspection readiness activities
- Collaborate with company US, UK, Canadian, Israeli and EU Clinical Research staff to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance.
- Lead and host (develop staff to lead and host) GCP, GLP and GVP inspections, provide follow up to any responses and corrective actions
- Deviations and CAPA:
- Develop and implement the Deviation and CAPA systems, including policies and electronic systems
- Lead and manage the Deviation and CAPA systems
- Ability to travel up to 25%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical or affiliated medical/clinical role. Advanced degree is desirable.
- Experience with vaccines or biologics along with cold chain in a pharmaceutical setting a plus.
- Experience in performing GCP, GLP, pharmacovigilance (GVP), and internal audits
- Experience with direct US and international health authority inspections and interactions
- Experience writing, evaluating and closing investigations and CAPA records.
- In-depth knowledge of and ability to apply GCP, GLP and GVP in conformance to US, EU and international standards
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
- Proven ability to develop and lead an international quality team.