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202609-123465 Global GMP Compliance Expert

  • Mississauga, ON, Canada

Full-time

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Job details

Job type
Full-time
Posting language
English
Posted

Original job description

At Roche, you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The 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**

More about this job

Responsibilities

Plan, conduct, and report GMP and GSDP audits across internal sites, affiliates, suppliers, and service providers, while leading inspection readiness and supporting site inspection management. Identify and mitigate global compliance risks, communicate regulatory trends, improve operating processes, and coach colleagues across the organization.

Requirements

Requires at least seven years of experience in a regulated industry, including five years in GMP auditing or regulatory inspection management, and a bachelor’s degree or equivalent in life sciences, pharmacy, or a related scientific discipline. Candidates should have deep knowledge of global cGMP and GSDP requirements, cross-functional coaching and influencing skills, and willingness to travel domestically and internationally; experience with diverse manufacturing technologies and product life-cycle management is preferred.

Skills

  • GMP Auditing
  • GSDP Auditing
  • Regulatory Inspection Management
  • Inspection Readiness
  • Global Compliance
  • Regulatory Intelligence
  • Risk Assessment
  • Risk Mitigation
  • Cross-Functional Collaboration
  • Coaching and Mentoring
  • Influencing Without Authority
  • Continuous Improvement
  • Quality Management
  • Product Life-Cycle Management

Visa sponsorship

Not detected in the job text

Categories

  • Healthcare
  • Manufacturing
  • Management & Leadership

Keywords

  • Good Manufacturing Practice
  • GMP
  • Good Storage and Distribution Practice
  • GSDP
  • Current Good Manufacturing Practice
  • cGMP
  • Global Compliance
  • Quality Regulations
  • Auditing
  • Regulatory Inspection Management
  • Inspection Readiness
  • Supplier Audits
  • Risk Assessment
  • Risk Mitigation
  • Regulatory Trends
  • Regulatory Intelligence
  • Continuous Improvement
  • Cross-Functional Collaboration
  • Coaching
  • Mentoring
  • Pharmaceutical Manufacturing
  • Biopharmaceutical Industry
  • Medical Device Industry
  • Manufacturing Technology Platforms
  • Product Life-Cycle Management
  • Life Sciences
  • Pharmacy

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