External Supply Quality Lead (12 Month Fixed Term/Secondment)

837 GlaxoSmithKline Inc.; Mississauga; Hybrid; CAD 92,000 - 142,000; Full time

Job summary

GlaxoSmithKline plc in Mississauga is seeking an External Supply Quality Lead for a 12-month hybrid contract. You will manage critical relationships with External Suppliers across a region, ensuring quality, compliance and strong collaboration with Quality, Regulatory and Procurement teams.

You will lead Quality Agreement negotiations, monitor supplier performance, drive risk management and ensure timely regulatory communications and CAPA implementation to secure a reliable source of supply.

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.
• 5 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.

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.

Skills

Data Integrity

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Supplier Auditing

Supplier Quality Management

Technical Writing

Education

Master's or PhD asset

Job description

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Job Purpose

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 a 12-month contract, an excellent way to explore other opportunities at GSK!

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.
• 5 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

• Master's 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.

Skills

• Data Integrity
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Supplier Auditing
• Supplier Quality Management
• Technical Writing

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer.

This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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 [e-mail].

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices.

The annual compensation for this role is CAD92,000 to CAD142,000 , determined based on experience, qualifications, and internal equity.

Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.

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