Director, Corporate Compliance - Quality Document Management - United States
- 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 Document Management.
- You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
- Controlled document processing, issuance, and change control
- Document storage and archiving
- Record retention program
- Good documentation practices
- Electronic records and data management
- Management of document templates
- Lead corporate-wide cross-functional team to assess, develop and implement document management systems and processes
- Implement a standard document management system and process across all functions and sites to achieve consistency and scalability
- Implement and manage electronic document management systems (e.g., controlled document processing, deviation/CAPA management)
- Ensure Part 11 compliance for electronic systems Periodically assess compliance to document management program requirements and procedures within company sites and Contract GxP organizations
- Ability to travel up to 15% Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in document management in the pharmaceutical industry
- Experience with GxP document management
- Experience with GxP IT systems
- Experience with direct US and international health authority inspections and interactions
- 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 a cross-functional and cross-site team.