Sr. Product Compliance Specialist

at  Johnson Johnson

Johnson & Johnson is currently recruiting for a Senior Product Compliance Specialist! This position will be located in Toronto, 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 role will be responsible for compliance to Johnson and Johnson Enterprise Quality Standards and Health Authority Regulations as it relates to the management of Janssen Canada Suppliers/Distributors, as well as the maintenance of the Drug Establishment License and the Medical Establishment License. The role will ensure appropriate programs are in place to meet business needs compliantly.

Position Summary:

• Preparation of documents for Establishment Licensing submissions.
• Ensure the quality functions with the Purchasing Controls process, including maintenance of the Approved Supplier List (ASL) and Approved Distributor List (ADL) are maintained.
• Ensure robust supplier and wholesaler quality agreements are implemented for required sites.
• Ensures deviations/non-conformances are investigated in a compliant manner and related corrective/preventive actions are in place.
• Ensure ongoing 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 leads change to those standards. This includes assessing impact on GMP quality requirements and regulatory filing (e.g. changes to test methods, manufacturing and packaging).
• Represent Product Compliance on product launches and site transfers.
• Ensures the timely and compliant release of product to the Canadian Market.
• Establishes efficient processes to ensure compliance and to generate and monitor key metrics to maintain performance expectations.

Key Responsibilities:

• 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 audits and monitoring).
• Ensure the ADL and ASL are kept up to date.
• Negotiate/implement supply site/wholesaler agreements ensuring company and Canadian regulatory requirements are met and which take full advantage of Canadian GMP’s and MRA frameworks where appropriate (Ensure Canadian requirements have been appropriately incorporated into the site’s procedures).
• Liaise/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.
• Assess APRs and Annual Stability Reports and negotiate with the manufacturing/testing sites to address deficiencies/issues.
• Identify, investigate and resolve non-conformances, corrective and preventive actions in collaboration with internal and external business partners with respect to product release issues. Actions include assessment of adequacy of the investigations and/or corrective/preventive actions planned or taken and the coordination of investigations across functional areas/suppliers.
• Initiate, assess, and perform tasks related to change controls applicable to Canadian products
• Build and maintain relationship with supply sites, wholesalers and key internal partners.
• 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).
• Direct, Coach, Assist and Mentor with the development of process users and Release Compliance team members.
• 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 self-inspections and support (direct interaction with auditors) HC GMP & Corporate audits.
• Guide and support the coordination of external supplier/vendor audits conducted by third-party, maintain audit plan and related documents in TrackWise system, and assess to ensure GMP compliance of sites.
• 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.
• Lead and/or participate in other quality projects as required.
• Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to recommend product disposition (approve/reject).
• Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC).
• Proficient in SAP and able to provide support to other users.
• Authorize the release of inventory in the SAP system ensuring accurate quantities, material status and expiration date.
• 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.

QUALIFICATIONS

Education:

• A minimum of a bachelor or equivalent University degree is required with a focus in Science, Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry preferred.

Required:

• A minimum 4 years Pharmaceutical Quality Control/Quality Systems.
• 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.

Preferred:

• Strong understanding of pharmaceutical production processes i.e. manufacturing, packaging, testing and process validation with pharmaceutical manufacturing experience.

Core/ Technical Competencies:

• 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.

Other:

• This position may require up to 10% domestic travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

• 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 audits and monitoring).
• Ensure the ADL and ASL are kept up to date.
• Negotiate/implement supply site/wholesaler agreements ensuring company and Canadian regulatory requirements are met and which take full advantage of Canadian GMP’s and MRA frameworks where appropriate (Ensure Canadian requirements have been appropriately incorporated into the site’s procedures).
• Liaise/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.
• Assess APRs and Annual Stability Reports and negotiate with the manufacturing/testing sites to address deficiencies/issues.
• Identify, investigate and resolve non-conformances, corrective and preventive actions in collaboration with internal and external business partners with respect to product release issues. Actions include assessment of adequacy of the investigations and/or corrective/preventive actions planned or taken and the coordination of investigations across functional areas/suppliers.
• Initiate, assess, and perform tasks related to change controls applicable to Canadian products
• Build and maintain relationship with supply sites, wholesalers and key internal partners.
• 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).
• Direct, Coach, Assist and Mentor with the development of process users and Release Compliance team members.
• 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 self-inspections and support (direct interaction with auditors) HC GMP & Corporate audits.
• Guide and support the coordination of external supplier/vendor audits conducted by third-party, maintain audit plan and related documents in TrackWise system, and assess to ensure GMP compliance of sites.
• 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.
• Lead and/or participate in other quality projects as required.
• Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to recommend product disposition (approve/reject).
• Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC).
• Proficient in SAP and able to provide support to other users.
• Authorize the release of inventory in the SAP system ensuring accurate quantities, material status and expiration date.
• 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