Associate Director, Quality Compliance Audits
Quality | Santa Monica, CA | Full Time
Kite 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
We are seeking a highly motivated individual to join us as a Director, Quality Compliance Audits to lead the Quality Assurance/Regulatory compliance programs including Global Center of Excellence for internal quality/regulatory compliance audits. This individual will direct programs to improve GMP compliance, as well as the content for the GMP training programs. Will also support the sites for the preparation and management of external audits and inspections by regulatory agencies.
- Directs the global, center-led internal audit program to verify compliance with global Good Manufacturing Practices regulations, and corporate requirements. Ensures appropriate corrective actions are taken when required. Assures tracking of corrective action commitments to completion and follow-up to assure sustained, effective implementation.
- Responsible to provide support for the preparation for, and management of external audits and inspections. Works directly with regulatory investigators. Reviews documents and provides input, coaching and feedback to promote continuous improvement. Works closely with senior facility management in managing the inspection process. Supports the response process as required. May review/edit regulatory submissions. Assures tracking of corrective action commitments to completion and follow-up to assure sustained, effective implementation.
- Collaborates with Corporate Quality Training in the creation of content and deployment of courses for the GMP/Quality Manual Training program. Assures communication of compliance concerns, regulatory agency expectations and industry trends as part of on-going education and training for GMP compliance.
- Works closely with Manufacturing in areas of GMP compliance. Acts as internal consultant and/or provides other resources with expertise. May assist in complaint investigations. May support the implementation of new manufacturing processes (process transfer), new facility start-up and/or the implementation of Quality Systems.
- Assures tracking of Audit key performance metrics and participates in periodic reviews to ensure suitability and effectiveness of the Quality System audit program. Identifies opportunities for improvement, as well as identification and implementation of appropriate actions.
- Responsible for budget and staff, as requested. Provides for the training and development of subordinates. Assures succession plan maintained.
- Develops and executes QA objectives in alignment with business plan goals and process improvement initiatives.
- Participate on teams developing global policies and procedures.
- Bachelor's degree in science or engineering discipline. Advanced degree a plus.
- Minimum of 10 years of experience in regulated industry, biologics or biotech.
- At least 7 years of management experience required.
- ASQ desirable.
- In depth knowledge of the regulatory environment for the manufacture of drugs, and biologicals products. Knowledge of blood/tissue components regulations a plus. Must possess thorough knowledge of global CGMP regulations and ISO standards.
- Strong leadership skills and demonstrated success in managing a team, both internal and external resources.
- Strong analytical and demonstrated problem solving skills
- Excellent verbal and written communication skills
- Success working with multifunctional, global teams.
- Excellent interpersonal/communication/influencing/negotiation skills required.
- Ability to travel up to 25%.
- Perform other duties as assigned.
Kite Pharma, is headquartered in Santa Monica, CA. To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.