Associate Director Quality - Apheresis Auditor

Job Responsibilities

Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers. qualification and audit of cell supplying vendors.

Perform qualification and audit of cell supplying vendors.

Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers. 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

Working knowledge of CFRs, EuDRA and associated guidances, regulations and annexes

Assist in Product Complaint investigations

Enforecement 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, Operate with minimum oversight

s, specific accountabilities and / or tasks, etc. associated with this job title include:

Understand contract language and the relevance to Quality, Facilitate quality agreements.

Liaison between Manufacturing site QA and Apheresis/infusion centers on quality related issues.

Essential 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.

Desired Requirements

• 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.

The annual base pay (or hourly rate of compensation) for this position ranges from $118,072 to $177,109 USD Annual. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.