Associate Director Quality - Apheresis Auditor

AstraZeneca•Gaithersburg, MD

22h

About The Position

This role provides Quality oversight to Apheresis, Cryopreservation, and infusion centers. The Associate Director will author and negotiate quality agreements, and participate in and support deviations, CAPAs, OOS, change controls, and product complaints involving these centers and cell supplying vendors. This position serves as a liaison between Manufacturing site Quality and Apheresis/Cryopreservation centers on quality-related issues, providing guidance, interpretation, support, training, and input on regulations, guidelines, company procedures, and policies. The role also offers audit readiness support for regulatory inspections related to Apheresis/Cryopreservation/infusion vendors and builds strong customer relationships with other functions to ensure compliance. The Associate Director will lead or participate in GxP audits/initiatives with other AZ Quality groups, assist in Product Complaint investigations, and enforce contractual obligations. Responsibilities also include conducting due diligence/audits/inspections, authoring quality procedures and presentations, and communicating across multiple levels within AZ and at external suppliers. The role involves participating in continuous improvement through Lean tools and principles, operating with minimum oversight, and understanding contract language relevant to Quality. Facilitating quality agreements is also a key aspect of this role.

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.
Operate with minimum oversight.
Understand contract language and the relevance to Quality.
Facilitate quality agreements.
Liaison between Manufacturing site QA and Apheresis/infusion centers on quality related issues.