Quality Assurance Supplier Manager - (Mt. Vernon, IN)
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Quality Assurance Supplier Manager (QASM) in Mt. Vernon, IN, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
As the Quality Assurance Supplier Manager, you will be responsible for the Quality management of assigned Locally managed Mt Vernon Suppliers. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: change control, product quality complaint and deviation investigations, quality issue management and escalation, product release, QA Agreements (establishment and maintenance) between AZ and External Suppliers.
Essential Job Functions:
- Planning for, supporting and participating in Regulatory Agency inspections.
- As needed, support WWAG Quality Assurance Audits of assigned Suppliers.
- Serve as supplier representative on Issue Management Teams.
- 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 Assurance Supplier Management including but not limited to: Annual Assessments; Quality Assurance 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 QA review and/or approval of the following cGMP documentation for their Suppliers:
- Change Requests.
- Product Quality Reviews (API and F&P PCOs only) or Supplier Quality Review (GDMS).
- CMC documentation (GEL) associated with changes or product establishment at Suppliers (API and F&P PCOs only).
- Quality Investigations (Deviations, Product Quality Complaints).
- 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.
- Proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).
- As a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s).
- Collaborates with, and influences to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices.
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to GES/AZ site leaders.
- Collaborates in data analysis and report creation on quality metrics and key performance indicators.
- Develops and maintains effective business relationships with Suppliers.
- Manages quality data and records in relevant quality management support systems (e.g. GCM, OCM, LIMS, SCM, etc.) as required and shares information during site Quality Councils.
- Assist in the production of, or contribution to, AZ quality documentation (including GES SOPs, Q & C Manual Procedures, etc.).
- Participates in the Mt. Vernon self-inspection program, auditing processes and procedures.
- Accountable for QA decision-making; works directly with the Supplier Management leader and other team members to deliver objectives.
- Bachelor degree in a science / technical field such as Pharmacy, Biology, 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, etc.
- 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.
Next Steps - Apply today!
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.
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.