Quality Leader

GSK•Mississauga, ON

1d•Hybrid

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. 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.

Requirements

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

Own and execute quality and compliance activities for Canadian Commercial and Contract Manufacturing (import/distribution of APIs and finished drug products).
Translate regulatory intelligence and global QMS updates into timely, inspection-ready actions that maintain cGMP compliance.
Prepare for, host, and support inspections/audits; manage issues in real time and drive post-inspection actions to closure.
Maintain and manage Drug Establishment Licenses (DELs): identify gaps, escalate risks early, and ensure on-time submissions/renewals.
Coordinate and deliver CPPs and GMP certificates for foreign markets with accuracy and speed.
Review, approve, and prioritize changes affecting products/processes (including NPI); keep product specs and master data aligned with registrations.
Provide oversight for batch record review and disposition, periodic product reviews, and quality trending; escalate and remediate adverse trends.
Lead investigations (complaints, deviations, incidents): ensure robust RCA, risk assessment, CAPA implementation, closure and effectiveness verification.
Create, revise, and approve SOPs and controlled documents (including Quality Agreements and Risk Assessments) with a focus on clarity and implementation.
Drive lean, agile improvements to simplify workflows, eliminate waste, and sustain stakeholder adoption.
Act as DEL and regulatory compliance SME; deliver training, mentor colleagues, and support vendors/3rd parties.
Manage purchase orders and invoices related to licenses, audits and regulatory fees as required.