The PositionThe Opportunity
- Drive global compliance excellence by planning, executing, and reporting on Good Manufacturing Practice (GMP) and Good Storage & Distribution Practice (GSDP) audits across internal sites, affiliates, suppliers, and service providers.
- Partner cross-functionally to identify global inspection and audit risks, developing strategic mitigation plans to safeguard our operational integrity.
- Lead end-to-end inspection readiness programs and support site inspection management to ensure continuous regulatory readiness across the network.
- Analyze and communicate emerging global regulatory trends and intelligence to proactively mitigate compliance risks and strengthen site-level practices.
- Champion a continuous improvement mindset by contributing to the evolution of our operating model, identifying efficiencies, and streamlining decision-making processes.
- Coach and mentor colleagues across the organization, fostering a culture of continuous learning, open feedback, and shared accountability.
Who You Are
- You bring 7+ years of professional experience in a regulated environment (such as pharmaceutical, biopharmaceutical, or medical device industries), with at least 5 years dedicated to GMP auditing or regulatory inspection management.
- You hold a Bachelor’s degree (BA/BSc) or equivalent in life sciences, pharmacy, or a related scientific discipline.
- You possess a deep understanding of global quality and compliance regulations, including cGMP and GSDP requirements.
- You demonstrate proven capability in coaching, influencing, and guiding cross-functional teams without direct authority.
- You are comfortable with domestic and international business travel as required by operational needs.
Preferred:
- Experience across diverse manufacturing technology platforms and product life-cycle management.
** Relocation benefits not eligible for this positions**
The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
