Nom du site: Mississauga Milverton Drive
Date de publication: Jan 24 2025
Are you passionate about ensuring product quality, compliance, and reputation at the global level? Join us as an External Supply Quality Lead in our #Mississauga office. In this #hybrid position, you’ll play a pivotal role in safeguarding GSK’s standards by managing critical relationships with our External Suppliers across a specific region. In this dynamic position, you’ll be the key liaison, building and maintaining strong, collaborative connections with multiple stakeholders, from Quality and Regulatory teams to Production and Site Management. You’ll also work closely with internal teams, including External Supply, Procurement, and Technical departments, to ensure seamless communication and exceptional quality outcomes. If you're ready to take on a challenging, impactful role where your expertise will directly contribute to GSK’s success, we want to hear from you!
*This is an 18-month contract, an excellent way to get your foot in the door!
**Posting expires on February 4, 2025 at 23:59 EST
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 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, and to drive routine GEMBA with purpose as defined in the GEMBA Plan in order to assess the Supplier on the shop floor.
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. Provide quality requirements for technical transfer projects, validation exercises, laboratory methods, stability protocols, SOPs, internals specifications, master batch records and others as needed.
Partner with External Suppliers and ES Procurement, Quality, Technical and Supply (PQTS+) to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product.
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 review of Quality Systems at the External Suppliers, to complement audit processes. Where required, support the External Supplier by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions.
Evaluate effectiveness of the External Supplier’s Quality Unit and systems and influence External Suppliers promoting 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 on the External Supply Quality Review Meetings, identifying Quality related issues and continuous improvement opportunities, with proposals to address these.
Review and respond to External Supplier regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspections and External Supplier responses to Regulatory observations prior to 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
Support or in some regions provide on time disposition of finished product manufactured by External Suppliers to meet supply chain demand.
Basic Qualifications
Degree in a Science or related discipline and at least 8 years experience in a Pharmaceutical company
Broad experience of cGMP and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processes
8 years' experience in various Technical and Operational Quality roles.
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.
Previous assignment experience promoting or requiring regional perspective desirable.
Project Management skills.
GPS exposure.
Preferred Qualifications
Masters or PhD and at least 6 years experience AND/OR equivalency in education and experience would be an asset.
Demonstrated sense of urgency.
Breadth in quality systems principles and practical application.
Good knowledge and demonstrated application of quality and risk management principles and tools.
Demonstrated sound decision-making process; based on facts & data, and application of Risk Management principles.
Technical knowledge of multiple dosage forms.
Demonstrated ability to effectively multi-task.
Strong Project Management skills and delivery.
Excellent verbal and written communication skills; with strong presentation skills.
Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
Strong problem-solving skills.
Proven ability to work and collaborate in cross-functional teams.
Demonstrated intercultural skills.
Excellent written and spoken language skills; primary English and any secondary language is desirable.
Demonstrated commercial acumen to effectively work with external companies
Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands.
Capable of working independently.
GSK est un employeur qui prône l'égalité des chances et s'engage en faveur de la diversité et de l'inclusion. Nous invitons toutes les personnes qualifiées à postuler à nos offres d'emploi. GSK s'engage à tenir compte des besoins des personnes handicapées. Si vous avez besoin d'un logement à n'importe quel stade de la procédure de candidature ou si vous souhaitez plus d'informations sur nos politiques de logement, veuillez nous contacter à l'adresse canada-recruitment@gsk.com. Merci de ne pas envoyer votre curriculum vitae à cette adresse électronique et de postuler via la procédure de candidature en ligne pour ce poste.
En tant qu’entreprise axée sur la santé et la science, GSK est résolue à suivre les recommandations énoncées par Santé Canada et à prendre toutes les mesures nécessaires pour aider à freiner la propagation de la COVID-19, ce qui comprend la vaccination contre la COVID‑19. Nous croyons fermement que c’est la meilleure façon d’aider à protéger ceux qui nous importent le plus : nos employés, les membres de nos familles et de nos collectivités, ainsi que les patients et les consommateurs que nous servons. À cette fin, nous avons pris une mesure de taille pour assurer la sécurité de nos employés pendant cette crise mondiale de santé publique.
Ainsi, seuls les employés entièrement vaccinés contre la COVID-19 peuvent se rendre à nos bureaux de Mississauga et de Laval (Montréal). De plus, tous les employés en contact direct avec les clients qui, dans le cadre de leur travail, fréquentent des établissements de soins de santé comme les hôpitaux, les pharmacies ainsi que les cabinets de médecins et de dentistes devront être entièrement vaccinés contre la COVID-19. Malgré ce qui précède, les employés peuvent demander une mesure d’adaptation pour des motifs liés aux droits de la personne, y compris des problèmes de santé ou des croyances religieuses. La santé et la sécurité de nos employés demeurent l’une de nos grandes priorités.
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