GSK is currently looking for a GMP Quality Assurance Manager to join our team. In this role you’ll manage specialty API, bulk drug substance, analytical testing, drug product, and/or packaging external manufacturing quality assurance operations and compliance activities with leadership and direction of R&D project team(s) and PSC supply, technical and specialty product team(s). Provide and/or facilitate decisions concerning the quality of material disposition or rejection. Responsible for the Operational Quality management relationship with strategic partners, alliances & external supply contractors for Specialty products. Responsible for assuring timely supply of product & maintenance of GSK reputation from a quality perspective. Contribute to the establishment of GSK Quality Standards for products within the scope of Specialty External Manufacturing. Manage issues and risks identified in area of responsibility.

Key Responsibilities:

• Recommend and manage implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met.
• Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met.
• Establish, implement and sustain an operational quality oversight model in compliance with GSK quality expectations & accounting for contractual complexities & strategic project requirements
• Supports the governance structure for quality oversight of External Suppliers that assures GSK product are in compliance with registered detail, QMS requirements and Specialty External Management Processes
• Directly manages external suppliers as assigned.
• Manage activities to ensure on time/Right First-Time testing and disposition of bulk drug substance & finished product manufactured by External Suppliers to meet supply chain demand.
• Assure quality issues are managed to safeguard GSK's patients, ensure business continuity & protect reputation.
• Contribute to and manage implementation of quality strategy from the QMS or from project leads as applicable.
• Where deviations from the above policies or the manufacturing process occur, e.g. registered detail, resolve, mitigate or escalate to senior management as judged necessary
• Actively manage records produced by External Suppliers, to ensure timely and appropriate outcomes for Quality and Production systems.
• Develop/negotiate or maintain quality agreements as required by QMS.
• Assurance that GSK's Quality Management System is applied to External Supply practices demonstrated through effective Quality Agreements, GSK Corporate audits & delivery of successful regulatory inspections.
• Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching and identification of specific inspectional risks.
• Report and drive resolution of cGMP/Regulatory compliance issues.  Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate, Legalized and Notarized Declarations and documents as required by for LOCs.
• Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
• Maintain regular dialog with team members, individually and collectively, providing feedback and recognition. Monitor the training status of direct reports

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS degree and at least 4 years’ GMP experience in biologics Manufacturing, QC, Engineering, Validation or Quality Operations OR Masters and at least 2 years’ experience GMP experience in biologics Manufacturing, QC, Engineering, Validation or Quality Operations

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Thoroughly knowledgeable of cGMP's and applicable ICH guidelines.
• Demonstrated sound decision-making skills.
• Demonstrated ability to lead work and collaborate within cross-functional teams.
• Strong verbal, written communication and presentation skills.
• Able to prioritize and decide appropriate course of actions.
• Strong Project Management skills.
• Solid understanding of Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Change Management.
• Leads root cause analysis activities as necessary using established tools.
• Supervisory experience necessar