Johnson & Johnson is currently recruiting for Senior Product Compliance Specialist! This position will be located Toronto Ontario, CA.

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/.

This position is responsible for the support/ownership of product compliance programs and activities 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.

• Perform Establishment Licensing process (i.e. reviewing annual requirements, obtaining necessary documentation from sites, preparing submissions, etc.) and direct communication with Health Canada foreign site unit on queries to Janssen Inc. Canada.
• Ensure the Purchasing Controls processes are effectively implemented and managed (e.g. supplier and site monitoring and audits, and maintenance of related documents in e-QMS).
• Build and maintain relationship with supply sites, wholesalers and key internal partners to implement agreements ensuring company and Canadian regulatory requirements are met in accordance to GMP's and MRA frameworks where appropriate (Ensure Canadian requirements have been appropriately incorporated into the site's procedures).
• Liase/Negotiate with Health Canada and/or manufacturing/testing/supplier sites to ensure all processes are addressed as appropriate i.e. Drug Surveillance, Group 3 Biologics, alignment with quality agreements and supporting programs.
• Identify, investigate and resolve non-conformances, corrective and preventive actions in collaboration with internal and external business.
• Partner/collaborate with key internal and external business partners to establish priorities, develop and manage systems/processes to support product compliance activities (Product release, GMP checks, validation review, APRs/Stability, Confirmatory testing, Executed Batch records, Inventory management, unique identifier, retain sample program, re-packaging at 3rd party operations).
• Support new product launches and product site transfers ensuring that all Master Records and release specifications/documentation meet Health Canada marketing authorizations. Negotiate with internal and external partners to resolve any gaps/deficiencies identified during this review.
• Lead and support Health Canada and internal audits (direct interaction with auditors).
• Develop and revise Standard Operating Procedures and Work Instructions as required and provide input to global and regional standards by ensuring that the Canadian perspective is integrated.
• Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC).
• Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to timely complete product disposition in SAP.
• Assess all data related to product returns to ensure all requirements are met for return to stock or recommend rejection.
• Develop, implement, maintain and improve business processes based on identified issues. Establish process metrics and monitor performance.
• Ensure on going product compliance to Canadian Regulations and J&J Quality requirements through review and evaluation of Annual Product Reviews (APRs), Annual Stability reports, Supplier Release Documentation and Executed Batch Reviews.
• Ensure regulatory compliance of all JI products through maintaining compliant specifications/standards (RSSs) and manages change to those standards. This includes assessing impact on GMP quality requirements and regulatory filing (e.g. changes to test methods, manufacturing and packaging).
• Initiate, assess, and perform tasks related to change controls applicable to Canadian products
• Lead and/or participate in other quality projects as required.

• B.SC. in Science with preference to Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry.
• Ability to lead and apply requirements of Post NOC changes and to interpret GMPs and application of their intent within the business environment.
• Understands principles of product change management and the impact on marketing authorization.
• 5 years Pharmaceutical Quality Control/Quality Systems.
• Strong understanding of pharmaceutical production processes i.e. manufacturing, packaging, testing and process validation with pharmaceutical manufacturing experience preferred.
• Proficient in SAP. Experience with S4 HANA is preferred.

• Delivers on commitments and is a positive role model for the Department/Division by modeling and inspiring high levels of ethics and integrity.
• Builds and Fosters networks and relationships to ensure collaboration and integration across all business partners and communicates effectively with Health Authorities or other Auditors.
• Ability to interpret GMPs and application of their intent within the business environment.
• Balance customer needs and business demands to move the business forward.
• Demonstrated sound judgment in managing risk on compliance matters resulting in positive outcomes.
• Promotes and leverages the contribution of people with diverse ideas, perspectives and backgrounds.
• Global and enterprise-wide mindset shaping short-term and long-term strategies by demonstrating innovative thinking and program development.
• Presents a united front by actively supporting team decisions.
• Displays resilience in the face of obstacles, adversity and/or major change while maintaining operating effectiveness.
• Manage multiple priorities including owning and balancing project management in addition to daily work.

• Job Location: Toronto ON, Canada
• Office Environment
• Occasional need to travel locally, within Canada and internationally.