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 QA Facilitator in West Chester, OH, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
As the QA Facilitator within the Process Execution Team (PET), you are accountable for all QA activities and decisions (end to end) that directly support execution of the PET mission. These activities and decisions include batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, regulatory interactions and may also include incoming material inspection and release. This leadership role, reporting to the Sr. Director, QA and the PET Leader (indirectly), is the single point of contact for all QA matters related to PET execution (quality, supply, and cost) and the primary link between the PET and other QA/QC functions.
Essential Job Functions:
• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Team (PET)
• Accountable for all QA decision-making in the PET; works directly with the PET leader and other PET members to deliver all PET objectives
• Provides direction, development, and performance management to the Quality
professionals supporting the PET; serves on the site Quality Assurance Leadership Team (QALT)
• Accountable for the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and the equipment and facilities utilized by the PET:
o Change Management (OCM)
o Batch Release decisions including Field Alert Assessments and Stop Shipments
o Quality Investigations (Deviations, Product Complaints)
o Validation Plans, Protocols and Reports
o Standard Operating Procedures & Risk Assessments
• May be accountable for release of incoming materials (bulk, APIs, excipients, packaging components,etc.)
• Collaborates with Quality Facilitators and Quality professionals from other PETs
• (including other sites) to ensure consistent application of the key quality systems across all PETs
• Interfaces with the Site Support Groups on improvement projects (capital and non-capital) that impact the PET, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects.
• Provides support to internal audits and regulatory agency inspections for queries relating to process execution activities
• Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the PET leader and PET members
• Ensures that the QA processes including batch record review, product disposition and quality issues resolutions are executed to maintain the flow of products and documents to meet PET objectives
• Serves as liaison in discussions and agreements with, and ensures timely communication to, other QA functions at the Site (Compliance and QC Labs)
• Serves as the liaison to global AZ supply sites and quality organizations; may also serve as QA representative to U.S. product supply teams
• Collaborates with other members of the PET to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
• Participates on internal task forces and external industry associations that evolve and transform the quality assurance discipline
• Bachelors degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering
• Minimum of 7 years experience in a leadership capacity
• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical
• Advanced knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment
• Demonstrated ability to influence leaders in a matrix environment and the personal
conviction to make courageous decisions to ensure patient safety and to protect company reputation
• Must display understanding of device or combination product regulations.
• Ten years experience in supervisory/managerial roles within QA in the Pharmaceutical Industry
• Advanced degree, Masters or higher
• Multiple site or function experience
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.