- 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.
- We are seeking a highly motivated individual to join us as a Director.
- 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 requirements.
- This role will be a hands-on resource reporting to the company quality head.
Responsibilities (include but are not limited to):
Responsible for working with the company quality team to :
- Develop and implement quality systems for company European operations
- Develop and implement company Qualified Person (QP) process for product disposition within the EU member countries.
- Assist in disposition issue resolution related to manufacture and testing of vectors and final product from US and European sites.
- Perform QP site and laboratory qualification activities for company
- Manage audits with Clinical Research Organizations (CRO), contract testing labs, contract manufacturing sites and raw material suppliers.
- Manage cross-functionally within company and externally to assure compliance and strong relationships with raw material suppliers.
- Collaborate with company Supplier Quality Management (SQM) and Supply Chain teams to improve:
- supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring.
- supplier QTA process and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed.
- Supplier initiated change notifications
- Monitor and report on meaningful performance metrics
- Provide leadership and direction for - SCARs, CAPAs, and Deviations.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Ability to travel up to 25%
- Perform other duties as assigned.
- Registered QP in The Netherlands.
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical or biologics role. Advanced degree is desirable.
- Previous experience managing and developing staff with a minimum of 6 years of experience.
- Experience auditing CMOs, CTLs and/or CROs.
- Experience with direct European Health authority inspections and interactions
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- In-depth knowledge of and ability to apply GMP 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.