This position is a one-year contract.
This position is responsible for the Quality oversight of assigned External Suppliers in an External Supply-specific Region to ensure MAH’s product quality, compliance and reputation are protected. Additionally, this role will involve establishing and maintaining an effective working relationship with the key contacts at each of the assigned external suppliers (s). These include key contacts with (but are not limited to) Quality, Regulatory, Business Development, Production, Site Management and others. The External Quality Manager must also develop and maintain an effective working relationship with internal stakeholders, including External Supply and Procurement Managers and contacts within Regulatory, Technical, Procurement, relevant internal GSK Sites and Local Operating Companies (LOCs) Quality functions.
Key Responsibilities:
- Lead Quality Agreement negotiations with External Suppliers and implement Quality Systems performance management with appropriate KPIs based on contractual parameters. Ensure regulatory compliance is managed through the flow of regulatory information to and from the releasing Sites as governed by Quality Agreements.
- 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 deviations, as a mechanism to propose continuous improvement initiatives. Apply appropriate Risk management tools with each External Supplier, escalating and tracking significant risks requiring resolution, including Risk Management System (RMS) reporting to the Quality Council, Local Incident Committee & Product Incident Review Committee (LIC, PIRC) or other corporate governance processes, as required to drive routine GEMBA with purpose as defined in the GEMBA Plan to assess the Supplier on the shop floor.
- Partner with external suppliers and ES Procurement, Quality, Technical and Supply (PQTS+) to ensure that potential quality and compliance issues are identified, communicated, and promptly resolved to ensure a secure source of supply for quality products. Liaise with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance. Provide specific GMP training for contractors, where deemed necessary. Review and disposition batch records when responsibility falls within EQ.
- Drive periodic reviews of Quality Systems at the External Suppliers to complement audit processes. Support the External Supplier by conducting GEMBAs and root cause analysis reviews to investigate issues and develop remedial actions where required.
- Evaluate the effectiveness of the External Supplier’s Quality Unit and systems and influence External Suppliers to promote robust systems operating under self-sufficient organizations. Escalate serious cGMP/Regulatory compliance issues following internal procedures. Support efforts that positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly distributed for incorporation in local action plans.
- Actively participate in the External Supply Quality Review Meetings, identifying quality-related issues and continuous improvement opportunities and proposing solutions.
- Review and respond to External Supplier regulatory inspections on matters that involve activities related to GSK products. Assess the impact of inspections and External Supplier responses to Regulatory observations before submission to the associated agency.
- Work with External Suppliers to establish effective CAPAs in response to GSK audit observations and ensure the Suppliers manage these to acceptable closure. Ensure timely communication of Quality Alert Issues. Coordinate and track any continuous improvement / Quality Plans deemed necessary. Support or lead internal audit processes where required.
- Support technical assessment and perform Quality assessment for new product introductions. Review and approve significant documentation associated with the introduction or transfer of a new or existing product to External Suppliers, including regulatory documents (e.g., PTDs, PIFs). Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internal specifications, master batch records, and others as needed.
- Support or, in some regions, provide on time disposition of finished products manufactured by External Suppliers to meet supply chain demand.
Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in a Science or related discipline
- At least 8 years of relevant experience in the pharmaceutical industry
- Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment
- Change Management experience
- Project Management skills
- GPS exposure
- Demonstrated decision-making capability based on facts & data and application of Risk Management principles
- Technical knowledge of multiple dosage forms
- Strong capability of statistical analysis of data trending
- Excellent verbal and written communication skills, with strong presentation skills
- Strong interpersonal and negotiation skills, with a demonstrated ability to influence stakeholders
- Demonstrated intercultural skills
- Excellent written and spoken language skills; primary English and any secondary language is desirable
- Capable of working independently
Job Posting End Date:
26 December 2024
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Contact information:
You may apply for this position online by selecting the Apply now button.
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