- 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.
- Our company is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.
- You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This individual will work cross functionally to develop our quality assurance systems and processes to meet all European GCP requirements.
- This role will be a hands-on resource reporting to the company quality head.
Responsibilities (include but are not limited to):
Responsible for the company Good Clinical Practice to:
- Develop and implement GCP quality systems for company European Clinical Research that follow International Congress of Harmonization (ICH) guidance, Competent Authority regulations and other relevant guidance
- Develop and implement internal company GCP systems that are inspection ready by EMA in all applicable areas of Clinical research including Clinical, Medical, and Pharmacovigilance areas
- Prepare and implement audit plans for all CROs, testing laboratories and clinical treatment centers
- Manage audit system and follow up on corrective action and CAPA to complete audit certifications
- Collaborate with our company US, UK and EU Clinical Research staff to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance.
- Lead, develop and implement all GCP regulatory inspection readiness activities
- Lead and host EMA inspections, provide follow up to any responses and corrective actions
- Provide leadership and direction for - CAPAs, Deviations, and other reports
- Provide periodic reports to company management on the quality and compliance status of the company GCP quality system and Clinical Research teams.
- Provide periodic reports on the GCP compliance status of all outside CRO, testing lab and treatment centers
- Ability to travel up to 25%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 6 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 a wide array of GCP audits
- Experience with direct European Health authority inspections and interactions
- Experience writing, evaluating and closing investigations and CAPA records.
- In-depth knowledge of and ability to apply GCP in conformance to US, EU and ROW 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.