Director, Corporate Compliance - Quality Systems - United States
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- 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 a Director, Corporate Compliance - Quality Systems.
- You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
You will work cross functionally among GxP functional areas and sites to develop and oversee our quality systems to meet all US, European and global Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance (GVP) requirements.
This position will report directly to the company Quality Compliance Head.
- Implement and oversee company’s GxP quality system:
- Create and/or revise policy (Program) documents to ensure requirements for each element of the quality system are defined
- Perform and/or ensure gap assessments are performed against defined requirements for each quality program
- Ensure implementation of the requirements for each quality program (e.g., through SOP implementation) across sites; ensure consistency;
- Update Quality Manual as required, to reflect revisions to quality system structure or elements
- Interface with program and process owners to achieve and maintain GxP compliance
- Own individual quality processes, as needed
- Draft and revise corporate SOPs, as needed
- Periodically assess compliance to quality system program requirements and procedures through audits of our company and contract sites
- Ability to travel up to 15%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 15 years’ experience in the pharmaceutical industry
- Experience with GxP quality system development, implementation and management meeting global regulatory agency/Board of Health requirements
- Experience with direct US and international health authority inspections and interactions
- Proficient in MS Word, Excel, Visio 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 a cross-functional and cross-site team.