At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Toronto, Ontario, Canada

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Commercial Quality (CQ) Product Compliance Process Lead to be located at Toronto ON, Canada.

The CQ Product Compliance Process Lead is responsible for the support/ownership of product compliance programs to establish and maintain regulatory and quality compliance in accordance with Johnson and Johnson Innovative Medicines and Health Authorities requirements for all imported/distributed product in the Canadian Market.

This role manages critical quality processes, driving end‑to‑end quality oversight of assigned products and projects, manages change controls, evaluates key GxP documentation, supports compliance initiatives across the LOC and affiliate sites, and drives process improvements by partnering closely with internal and external teams to maintain robust product quality and operational excellence.

Key Responsibilities:

Regulatory & Product Compliance

• Maintain compliant product specifications/standards and manage associated changes, including assessment of GMP and regulatory filing impacts.

• Ensure timely and compliant product release to the Canadian market.

• Review analytical, manufacturing, and packaging documentation to recommend product disposition.

• Monitor ongoing product compliance through review of APQRs, stability reports, supplier documentation, and executed batch records.

• Lead change controls, ensuring timely assessments, documentation, and closure.

• Lead new product launches and site transfers, ensuring all documentation aligns with Health Canada marketing authorizations.

• Provide SAP expertise and authorize product inventory release.

• Manage product return assessments and oversee complaint intake, follow-up, and trend evaluation.

Quality Systems and Audit readiness

• Support LOC and affiliate sites with compliance and quality improvement initiatives.

• Develop and improve processes and metrics to ensure regulatory and quality performance.

• Evaluate changes to master production documentation in alignment with regulatory requirements.

• Conduct self‑inspections and support Health Canada Inspections and Corporate audits.

• Supporting quality documentation such as Supplier Assessments, GMP compliance documentation for DEL, Supplier Quality Agreements, and Health Canada/J&J audit support.

Quality Leadership & Issue Resolution

• Act as a QA subject‑matter expert and “go‑to” resource for cross‑functional teams.

• Lead, investigate, and resolve non‑conformances (NCs) and CAPAs, coordinating across functions and suppliers.

• Provide expert rationales for product disposition, risk assessments, audit responses, and compliance decisions.

• Troubleshoot complex quality and compliance issues using technical expertise and creative problem‑solving.

Supplier & Partner Management

• Support the supplier lifecycle—including selection, qualification, maintenance, and disengagement—for indirect suppliers, wholesalers, and distributors.

• Build strong relationships with supply sites, wholesalers, and internal partners.

• Collaborate with internal and external business partners to support compliance activities (DEL, APQRs, executed batches, inventory, confirmatory testing, quality agreements, retain samples, and re‑packaging operations).

Operational & Team Leadership

• Act as Manager Delegate for approvals of program plans, specifications, and compliance records.

• Prepare, review and/or Approve SOPs and Work Instructions; contribute to global/regional standards from a Canadian perspective.

• Coach, mentor, and develop Product Compliance Specialists, contractors, and co‑op students.

• Establish KPIs, manage workload planning, and drive team performance.

• Other departmental tasks as assigned.

Qualifications

Education & Experience

• B.Sc. in Pharmacy, Chemistry, Microbiology, Biotechnology, Biochemistry, or equivalent life science degree.

• A minimum of 6 years of pharmaceutical industry experience in Quality Assurance

• Working experience in a Canadian importer/distributor environment is preferred.

• Experience in pharmaceutical manufacturing, packaging, testing, and process validation.

• Strong working knowledge of Health Canada’s GMPs and Medical Device Regulations

• Demonstrated GMP investigation and audit experience.

• In-depth knowledge of change control management and regulatory impact assessment processes.

• High integrity with a strong commitment to quality and compliance.

• Exceptional collaboration and communication skills; able to interface effectively with Health Authorities and auditors.

• Strong judgment in risk‑based decision‑making.

• Ability to manage multiple priorities in a fast‑paced, dynamic environment.

• Inclusive leadership style that fosters diverse perspectives.

• Strategic mindset with strong analytical and problem‑solving capabilities.

• Resilient, adaptable, and team‑oriented.

• This position may require domestic and/or international travel.

Required Skills:

 

 

Preferred Skills:

Collaborating, Communication, Compliance Management, Data Quality, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis

 

 

The anticipated base pay range for this position is :

$90,300 to $140,300

Additional Description for Pay Transparency:

As applicable for the role - Under current guidelines, this position is eligible for a discretionary performance bonus.​ The Company uses Artificial Intelligence in its assessment of applicants.​ This job posting is for an existing position.