Associate Director Quality - Apheresis Auditor
About The Position
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
Requirements
- Bachelors Degree and Minimum 7 years’ experience working in GMP Quality with direct experience in compliance and auditing.
- 15 + years of applicable experience with an Associates Degree.
- 20 + years of applicable experience with a High School Diploma.
- Knowledge of CGT products for clinical use in humans.
- Working knowledge of CFRs, EuDRA and associated guidances, regulations and annexes.
Nice To Haves
- Advanced Degree.
- Experience writing and reviewing SOPs and other quality documents.
- Well-developed knowledge of electronic quality systems (e.g., SAP, Veeva).
- A broad and comprehensive understanding of investigational medicinal products.
- Experience in auditing and qualification of Apheresis/Infusion centers or Cryopreservation centers for CGT products.
Responsibilities
- Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers.
- Perform qualification and audit of cell supplying vendors.
- Provide Quality oversight to Apheresis, Cryopreservation and infusion centers.
- Author and negotiate quality agreements.
- Participate and provide support to deviations, CAPAs, OOS, change controls and product complaints involving Apheresis and Infusion centers and cell supplying vendors.
- Liaison between Manufacturing site Quality and Apheresis/Cryopreservation centers on quality related issues.
- Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
- Audit readiness support for regulatory inspections queries related to Apheresis/Cryopreservation/infusion vendors.
- Build and maintain strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate in GxP audits/initiatives with other AZ Quality groups.
- Assist in Product Complaint investigations.
- Enforcement of contractual obligations.
- Conduct of due diligence/audits/inspections, Author quality procedures and presentations.
- Written and oral communication across multiple levels within AZ and at external suppliers.
- Participate in continuous improvement through the use of Lean tools and principles.
- Understand contract language and the relevance to Quality, Facilitate quality agreements.
- Liaison between Manufacturing site QA and Apheresis/infusion centers on quality related issues.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
