Product Quality Lead

This is what you will do:

• The Product Quality Lead (PQL) is responsible to provide product quality stewardship of our products from introduction throughout the lifecycle. As the product quality guide, the PQL will build the strategy to proactively minimize product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation. The PQL is the Quality liaison between Regulatory Affairs and Operations to ensure regulatory compliance of manufacturing and testing processes. The role enables efficient communication and decision making related to the quality of our products.

You will be responsible for:

• Proactively handle product quality risks ensuring they are proactively mitigated, actioned, and advanced to senior management 
• Assess data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs
• Act as Quality advocate and single point of contact for global program strategy teams to ensure consistent quality approach to GMP manufacturing, testing, release, and regulatory filings.
• Act as Quality guide for product quality history through lifecycle
• Maintains Product Quality Monographs and Supply Chain Maps in compliance with investigational product and commercial marketing applications
• Authors Global Annual Product Quality Reports, coordinating with leads of supplying chapters, and runs commitments to closure.
• Provides lead quality review of CMC sections of Regulatory submissions and response to queries.  Facilitates management and closure of post marketing regulatory commitments. 
• Lead Stability Review Boards to enable primary Quality oversight of the stability program including ensuring annual commitments are met. 
• Primary Quality oversight of product specifications and reference standard program with a focus on ensuring supply
• Supports process lifecycle and analytical lifecycle management initiatives
• Partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc.
• Facilitates global changes with respect to the product
• Provides support where needed in the creation of Quality Target Product Profiles and product characterization and comparability assessments in line with regulatory expectations
• Supports Health Authority inspections and compliance

You will need to have:

• 10 years GMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment
• B.S / B.A. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry

We would prefer for you to have:

• Previous experience in product lifecycle management, including pre-clinical to commercial phases

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.