we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
Join us as member of the Global Supplier Quality Organization! There are currently 4 SQSMs that support AstraZeneca's Biologic products. You and your Bio colleagues will be based at our Bio Hub in Gaithersburg, Maryland. We have a dynamic team that supports all our Bio products globally to help patients live better lives.Biologics is one the AZ's fastest areas of growth.
As the Senior Quality Supplier Manager
, you will provide Quality oversite of Biologic CMO's globally. This role requires experience in Mammalian Cell Culture Production to include monoclonal antibody production, Microbial Fermentation, Drug Product filling, and Label and Packaging.Main Responsibilities:
- Responsible for Quality management of assigned External Suppliers (contract manufacturer's and/or outside testing laboratories) and Quality management of assigned Supply Chains or third-party customers.
- Delivering on Quality activities that directly support both execution of Quality Management of Suppliers for assigned suppliers and execution of the Product Supply Chains for primarily Biologics External Sourcing or Global External Sourcing, supply to customer. This includes, but is not limited to:
- Quality System oversight and/or performance of the following activities: change control, product quality complaint and deviation investigations, quality issue management and critical issue, product release
- Quality Agreements (establishment and maintenance) between AZ and External Suppliers, between GSQ and AZ Operations Sites and between AZ and Third Parties.
- Supporting Quality Directors during issue management of quality issues impacting the ability to provide the right product at the right time to the customer and taking the lead for GSQ in IMTs.
- Serving as the primary interface between Quality and the Supply Chain Leads / 3rd Party Customers (as required); and as the Quality leader role in the critical issue of quality supply chain issues.
- This position requires strong cross-functional ways of working with non-Quality members across the Supply Chain.
- Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites)
- Responsible for Quality Supplier Management including but not limited to:
- Annual Assessments
- Quality Agreements
- Trending and reporting of data
- Assessing, reviewing and improving quality systems at Suppliers;
- Attendance at Quality and Business Review Meetings
- Maintains a high level of understanding of meaningful biologic production processes and quality systems.
- Performs the Quality review and/or approval of the following cGMP documentation for their Suppliers: Change Controls, Quality Investigations (Deviations, Product Quality Complaints), and Validation Plans, Protocols and Reports
- Responsible for quality issues escalation and resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.
- Actively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).
- Supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)
Next Steps - Apply today!
- Bachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering.
- 7+ years of industry experience
- Validated broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role
- Strong proven knowledge of Biologic processes, cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
- Proven experience working cross- functionally and leading significant improvement initiatives
- Ability to work independently under your own initiative.Ability to travel as required approximately 25% of their time.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.