Senior Manager, QA Operations
GlaxoSmithKline is hiring Senior Manager, QA Operations.
- BSc/BEng in a Science or Engineering discipline and at least 8 years experience; OR Masters or PhD and at least 6 years experience; AND/OR equivalency in education and experience.
- A range of experience in various Technical and Quality Assurance roles across multiple dosage forms.
- Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
- Good knowledge and demonstrated application of Quality and Risk Management principles and tools.
- Project Management skills.
- Prior experience auditing either external or internal groups.
- Change Management experience.
- Operational Excellence exposure.
- Line Management experience desirable.
- Previous assignment experience promoting or requiring global perspective desirable.
Reporting to the Region CMO Quality lead, the primary responsibilities of this role are to lead, coach, develop, provide guidance to a team of Quality Managers, who work as key members of the respective Supplier Relation Teams. The individual in this role works jointly with the Supply organization to provide for a timely and reliable supply of quality products.
This role has the responsibility for Quality Operations in one or more Supplier Relation Teams, establishing and maintaining an effective working relationship with CMO(s) to ensure GSK’s product quality and reputation are protected.
The job purpose is to continuously improve, harmonise and establish QA and Compliance systems in CMO across the SRTs, strengthen quality awareness, implement the development of third party strategic plans, support Quality Operations Managers to carry out product/process improvements, to eliminate barriers, and investigate quality issues using applicable process improvement and problem solving techniques for successful outcomes.
The CMO Quality Group / Cluster Lead undertakes the following responsibilities:
- Lead the Product Incident Review Committee (PIRC) within the allocated dose form/category cluster
- Quality input into CMO dose form/category sourcing strategies, requiring global matrix leadership across respective Group Leaders.
- Running Quality Governance processes
- Leading strategic improvement projects.
- Lead directly a group of Quality Managers who manage the interface and performance of CMOs over which GSK does not have direct control. This requires a high focus on influencing, building good relationships with key individuals, handling well pressure and recoursing to contractual requirements when necessary.
- Accountable for delivery of NPI within the Supplier Relation Team and is required to resolve technical and regulatory issues, supporting the Quality Managers when requiring advanced knowledge and experience.
- Run the Product Incident Recall Committees within designated CMO / product portfolio. Responsible for ensuring root cause analysis is performed and appropriate recall decisions proposed in line with GSK regulatory and quality expectations. The person in this role would be certified to lead PIRCs.
- Ensure there are investigations into significant quality incidents arising at suppliers and ensure root cause of the problem is identified and appropriate corrective and preventative actions are implemented.
- Ensure there is appropriate communication, cascading of information, prompt escalation of significant issues or risks across the organization, driving prompt resolution of issues. Actively participate in GSK management review forums. Drive periodic review of quality systems at CMOs and lead Quality agenda in relevant Business Review meetings
- Implement Quality Systems performance management with appropriate Key Performance Indicators. Track and provide supplier performance feedback to drive continuous improvement through the team of Quality Managers.
- Ensure that CMO facilities and systems meet and maintain current regulatory requirements & expectations and report all potential and actual cGMP/Regulatory compliance issues. Ensure approved Quality Agreements are in place for assigned CMOs.
- Ensure there is appropriate application of risk management by identifying potential short comings in supplier’s quality systems, considering the risk to patient safety and efficacy, product integrity, regulatory compliance and GSK business.
- Provide quality input to ensure sourcing strategies are appropriately defined and implemented over time frames of 2-5 years.• Review and respond to CMO regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to associated agency.
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