- Shape the implementation of Global R&D Quality Strategies, Projects, Systems, and Quality Operations for Gene Therapy Product Development.
- R&D Quality Site operations head of Pasadena Cell and Gene Therapy site.
- Develop R&D Quality strategies for Phase appropriate Quality Assurance during the Early Phase Product Development stage for Cell and Gene Therapy products.
- Ensure regulatory compliance with cGMP, GSP, and other GxP requirements.
- Lead tactical aspects of inspection readiness activities across global R&D manufacturing sites.
- Be the Head of Site Quality Operations for R&D Develop and Implement R&D global quality systems and procedures following CSL Global R&D Quality Management System (QMS).
- Primary representative for R&D Quality in site quality management forums and discussions; including Global R&D Expert Team Meetings.
- Develop Phase-appropriate Quality systems for North American manufacturing sites.
- Chair and Manage GMP Quality Management Review meetings for Global Product Development for Gene Therapies Product Development.
- Direct appropriate resourcing model and budget management within PDRQ by strategic assessment of workload, required planning for staffing, coordination of consultant activities, and ongoing review of forecasted expenditures.
- Represent R&D Quality as a senior member of the Global Change Control Panel.
- Provide QA disposition on R&D deviations/CAPAs and Investigations for R&D clinical trial materials and Non-Clinical Toxicological studies.
- Manage the R&D quality unit to provide change control, batch release, and deviation management responsibilities for R&D Cell and Gene Therapy Product Development
- Conduct internal audits of R&D areas as they relate to pre-Clinical trial materials and clinical materials manufacture and management of the R&D internal/external audit schedule.
- Help with 3rd Party Quality audits to support Gene Therapy Product Development.
- Guide and implement Quality Continuous Improvement Projects.
- Develop business relationships with local and global quality sites where manufacturing operations are shared between sites.
- Develop quality indicators with main PD partners to ensure the effectiveness of quality systems within Cell and Gene Therapy Product Development.
- Attend and provide Quality oversight for PDETs, Technical Transfer, and CMC meetings for new Product Development projects.
- Manage performance and development of R&D Managers.
- Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development.
- Implement inspection readiness activities across global R&D manufacturing sites.
- Develop and implement a "Quality on the Floor" culture.
- Bachelor's degree in pharmacy, Chemistry, Biology, or Biochemistry is desired.
- Advanced degree preferred.
- 8+ years' experience in quality in the pharmaceutical/biotech industry with 3 years' leadership/team management experience.
- Demonstrated knowledge of GxP, domestic and international regulation.
- Demonstrated knowledge of processes and registered condition.
- Experience applying Quality Systems.
- Previous experience to grow and development talent.
- Continuous improvement mindset.
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Associate Director, Quality Assurance - Pasadena, United States - CSL Behring
Description
Job Description
The Opportunity:CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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