Site Name: Mississauga Milverton Drive Posted Date: 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. 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. GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.