Quality Leader (Contract)

GSKMississauga, ON
CA$98,000 - CA$148,000

About The Position

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 prevent and treat disease with specialty medicines, vaccines and general medicines. We focus on the science of the immune system and advanced technologies, investing in four core 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 perform 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 We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 33 medicines and vaccines manufacturing sites delivered 1.64 billion packs of medicines and 389 million vaccine doses in 2025 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 Join GSK’s Canadian Commercial team to lead quality excellence for the importation and distribution of finished drug products. You will own the implementation and continuous improvement of the Quality Management System, use risk-based judgment to guide decisions, and champion lean, agile process changes that speed delivery without compromising compliance. This fast-paced role demands proactive ownership, spotting compliance risks early, driving corrective actions to closure, and keeping stakeholders informed with clear, timely updates. This is a 12-month contract, an excellent way to get your foot in the door!

Requirements

  • Bachelor of Science or Engineering or equivalent.
  • 5 years’ experience in the pharmaceutical industry.
  • 3 years’ leadership (formal or informal) with proven ability to influence, coach, and lead cross‑functional teams.
  • Strong knowledge of QA systems and cGMP regulatory requirements, including importation/distribution and contract manufacturing expectations.
  • Proven experience making risk‑based quality decisions and performing quality risk assessments.
  • Hands‑on experience supporting or hosting health authority inspections (audit readiness, hosting, follow‑up).
  • Proficient with SAP transactions and Veeva document management (VQD/VQMS) required.
  • Advanced, practical use of AI to improve productivity and quality (e.g., drafting/reviewing controlled documents, summarizing/analyzing data), applied in accordance with company policies and data/privacy rules.
  • Familiarity with manufacturing/packaging processes and drug product testing; supply chain experience is an asset.

Nice To Haves

  • Experience in importation, market release, or distribution quality activities.
  • Prior leadership experience or demonstrated ability to lead projects and mentor colleagues.
  • Experience with Quality systems software and ERP tools.
  • Working knowledge of trend analysis, product performance reviews, and metrics reporting.
  • Experience preparing for and supporting regulatory inspections.
  • Ability to work collaboratively across teams and influence stakeholders at multiple levels.

Responsibilities

  • Coordinate, lead, and execute quality compliance activities supporting the Canadian Commercial business (Importation/Distribution Finished Drug Products) and Canadian Contract Manufacturing business (Importation of APIs/Finished Drug Products and Distribution Finished Drug Products), taking end-to-end ownership of deliverables.
  • Assess quality regulatory intelligence and global QMS changes; translate requirements into timely actions, ensuring cGMP standards are implemented, maintained, and inspection-ready.
  • Actively participate in and/or host inspections and audits, including preparation, real-time issue management, and driving post-inspection actions to closure on committed timelines.
  • Manage the Drug Establishment Licence (DEL) for all relevant sites and activities; proactively identify gaps, escalate risks early, and ensure on-time submissions/renewals.
  • Manage requests for CPPs (Certificate of Pharmaceutical Product) and GMP certificates for foreign markets, as required, ensuring accuracy and timely completion.
  • Coordinate, review, and approve changes impacting products/processes (including new product introductions) and maintain product specifications and master data in line with registered requirements, prioritizing workload to meet business and compliance timelines.
  • Provide quality oversight for batch record review and disposition (release/reject), Periodic Product Reviews, and product quality trending; take action on adverse trends and ensure timely, effective corrective actions.
  • Lead or participate in investigations (complaints, deviations, and product incidents), ensuring robust root cause analysis, risk assessment, and timely CAPA implementation; drive actions through to closure and verify effectiveness.
  • Create, revise, and approve SOPs and controlled documents (including high-complexity documents such as Quality Agreements, Quality Risk Assessments, and Registration files, as required) with a focus on clarity, usability, and compliance; ensure updates are implemented (not just written).
  • Drive process improvement to create lean, agile, and efficient quality/compliance processes; remove waste, simplify workflows, and sustain adoption with stakeholders. Act as a subject matter expert in DEL and Regulatory Compliance matters; provide

Benefits

  • 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 [email protected].
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