CMO Quality Manager

Job Purpose

• Reporting to the CMO Quality Group/Cluster Leader, as a key member of the Supplier Relation Team (SRT), this position is responsible for managing the relationship with assigned 3rd Party Manufacturer in the Region from a Quality perspective to ensure GSK’s product quality and reputation is protected.

In this role

• You ensure that all aspects of the products at assigned third party contractor sites comply with the requirements of the GSK GSK Quality Manual and meet relevant cGMP regulatory and legislative requirements, through defined key performance and quality indicators,
• You assess the risk, identify gaps and implement quality action plans at assigned CMOs and you communicate to the organization so the risks are proactively addressed
• Additionally this role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO(s).
• These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others.
• The CMO Quality Manager in partner with the Supplier Relation Manager (SRM), must develop and maintain an effective working relationship with internal stakeholders and all members of the SRT, including other members of External Supply including Supply and Procurement Managers, as well as contacts within Regulatory, Technical, Procurement, relevant Category Quality functions.

Key Responsibilities :

• Be the point of contact for Quality matters with the assigned 3rd party supplier.
• Ensure that all aspects of the GSK products at assigned third party contractor sites comply with the requirements of the GSK Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
• Evaluate effectiveness of the CMO’s Quality Unit and systems and influence External Suppliers promoting robust systems under self-sufficient organizations.
• Escalate all serious cGMP/Regulatory compliance issues.
• Monitor the quality performance of the External Supplier driving remedial action where necessary.
• Monitor and assess external suppliers’ key performance indicators, such as complaints and Right First Time as a mechanism to propose continuous improvement initiatives.
• Apply appropriate Risk management tools with each CMO/External Supplier in scope, escalating and tracking significant risks requiring resolution, including complaint monitoring and trending, reporting to Quality Council, Product Incident Review Committee (PIRC) or other corporate governance processes, as required.
• Ensure that investigations associated with assigned third party sites are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure.
• Support and lead internal audit processes where required.
• Ensure timely communication of Quality Alert issues. Co-ordinate and track any remediation deemed necessary.
• Ensure the LOC (Market QA) is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
• Drive periodic review of Quality Systems at the CMO, to complement audit process.
• Conduct root cause analysis reviews for identification of issues and development of remedial actions.
• Review and respond to External Supplier 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 the associated agency.
• Work with CMO to establish meaningful CAPAs, in response to GSK audit observations and manage to acceptable closure.
• Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned third party sites.
• Take the lead to ensure that any commitments given to address audit observations (both GSK and Health Authority) by assigned third party sites are implemented as described in the agreed time frame.
• Support new product introductions from an operational perspective.
• Eventually review and approve significant documentation associated with the introduction or transfer of a new or existing product to CMO