Commercial Quality Product Compliance Manager

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 https://www.jnj.com

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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 Commercial Quality Product Compliance Manager to be in Toronto ON, Canada. This position is a fixed-term role of 18 months.

The Commercial Quality Product Compliance Manager is responsible for management of product compliance programs and quality functions to establish and maintain Johnson and Johnson Innovative Medicines licenses required to import and distribute Drug, Medical Device and Controlled Drug and Substances products in the Canadian Market.

You will be responsible for:

• Establish and maintain Drug and Medical Device Establishment Licensing processes.
• Manage the quality functions and processes within the Purchasing Controls system including the Janssen Inc. Approved Supplier List (ASL), Approved Distributor List (ADL), approval of supplier audit reports and quality agreements to comply with Canadian GMPs, and MRA frameworks and J&J quality standards.
• Ensure the Purchasing Controls processes and systems are effectively implemented, remediated, and managed.
• Ensure quality issues associated with Significant Safety Issues (SSI) are reported to Health Canada in accordance with the Food and Drug Regulations (FDR)
• Ensure SOPs that are developed which describe the product acceptance process at Janssen Inc. are reviewed, approved and implemented and are aligned with Corporate and Health Canada requirements.
• Ensure the accurate and timely maintenance of product specifications and standards used by the team to release product.
• Responsible for ensuring that all products released in the Canadian Market are manufactured, packaged, tested, transported and distributed to ensure compliance with their Marketing Authorization.
• Responsible for ensuring that all key product support programs (Annual Product Review, Executed Batch Review, Confirmatory Testing, Unique Identifiers, Stability review program etc.) are managed effectively and efficiently
• Work in close partnership with RA, Supply Management and Sales and Marketing to determine workload and priorities for resource allocation.
• Ensure Janssen Inc. is kept up to date with J&J Affiliates and 3rd Party Electronic Systems / applications and processes, which ensure quality/regulatory are effectively and efficiently linked to global change management programs.
• Coach/mentor staff on the assessment of deviations/non-conformances (either internal or external) and other technical issues, to ensure that all issues are adequately understood and that reviews and approvals are based on sound, risk-based rationales.
• Lead or participate in local, regional or global cross functional teams to ensure adequate investigation, risk assessment, identification and implementation of required actions to address product quality issues related to deviations and CAPAs
• Lead or represent CQ for escalation of issues related to products marketed in Canada
• Lead and/or participate in local, regional, or global cross-functional project teams
• Lead CQ representation on new product launches and product site transfer teams
• Lead CQ representation on Licensing & Acquisitions and Out Licensing opportunities
• Review practices, procedures, and normal operating routines to identify differences with emerging and existing Health Canada interpretations of the GMPs and make appropriate changes.
• Make recommendations to Director - Commercial Quality to correct process deficiencies or to implement process improvement
• Support/back up Director, Commercial Quality
• Support Quality Systems Manager as needed
• Ensure alignment and integration into Global J&J Systems and Standards, approve local procedures.
• Ensure adoption of new or revised Regulatory Requirements
• Contribute to the development and implementation of the strategic direction and priorities for the department.
• Manage, coach and develop direct reports with coaching responsibilities.
• Perform audits as required. Management of audit-related activities prior to and during audits.

Qualifications / Requirements:

• BSc in Life Sciences (Pharmacy, Biology, Chemistry, Microbiology, Biotechnology, or Biochemistry) or equivalent.
• Minimum of 8 years Pharmaceutical Quality / Regulatory experience
• People management experience with the ability to motivate, develop, and coach direct reports.
• Experience in a pharmaceutical importing/distributing environment
• Knowledge of Post NOC changes.
• Strong ability to negotiate and influence key stakeholders (internal & external).
• Understanding of Pharm processes (including manufacturing, packaging and validation).
• Strong knowledge of Canadian Regulatory Requirements and interpreting their intent.
• Proficient in TrackWise, Document Management Systems, SAP, Sales Force and Microsoft Office applications.
• Excellent communication (verbal and written) and strong interpersonal skills.
• Demonstrated sound judgment in dealing with risk on compliance matters.
• Well defined problem solving and analytical skills.
• Manage multiple priorities including owning and balancing project management in conjunction with daily work.
• Superior attention to accuracy and details

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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