AstraZeneca Pharmaceuticals LP Quality Supply Manager in West Chester, Ohio
At AstraZeneca 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.
The Quality Supply Manager is responsible for the Quality management of assigned External Suppliers within the Category Team and sub Category Team (CT & sCT) [for Direct Material Supplier (DMS) PCO] and/or the API & F & P PCO Supplier management teams. They are responsible for all Quality activities that directly support execution of Quality Management of Suppliers for assigned suppliers. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: change control, product quality complaint, S&L complaint and deviation investigations, quality issue management and escalation, product release (Career Level D required), Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between GSQ and AZ Operations Sites.
Within the Global Supplier Quality (GSQ) organization the job holder is responsible for the oversight and ownership of Quality System(s). They will support the Quality Professionals involved in Quality Supplier and Product Supply Chain Management within the assigned categories.
In addition, the preparation and submission of periodic Supplier Quality Assessments, Regulatory Agency interactions and serving as Quality leaders on NPI, new supplier introductions, In Licensing, strategic sourcing projects, process optimization and product transfer projects, as these relate to Quality Supplier management, are within the scope of this role. Regulatory Agency interaction includes preparation for, and management of, Regulatory Agency inspections at External Suppliers and AZ sites (when External Suppliers are assessed).
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).
As needed, perform Quality Audits within their technology area, as a Guest Auditor on the WWAG lead audit team.
Liaise with Suppliers to ensure successful delivery of projects.
Make decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise.
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 relevant production processes and quality systems.
Performs the Quality review and/or approval of the following cGMP documentation for their Suppliers:
o Change Requests
Product Quality Reviews (API and F&P PCOs only) or Supplier Quality Review (DMS)
o CMC documentation (ANGEL) associated with changes or product establishment at Suppliers (API and F&P PCOs only)
o Development and technology transfer documentation (API and F&P PCOs only), along with Director, Supply and Quality Systems, Global Supplier Quality
o Quality Investigations (Deviations, Product Quality Complaints and S&L Complaints)
o Validation Plans, Protocols and Reports
Education, Qualifications, Skills and Experience:
Bachelors/Masters degree in a science / technical field such as Pharmacy, Chemistry or Engineering
Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role.
Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards.
Excellent oral and written communication skills
Demonstrated experience working cross- functionally and managing significant improvement initiatives (e.g. project management skills)
Strong problem solving skills
Strong negotiating/influencing skills
Ability to work independently under his/her own initiative.
Ability to travel nationally and internationally as required approximately 10% of their time
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.