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 **Job Function:** Quality **Job Sub** **Function:** Customer/Commercial Quality **Job Category:** Professional **All Job Posting Locations:** CA003 ON Toronto - 19 Green Belt Dr **Job Description:** Johnson & Johnson is currently recruiting for a Senior Quality Release Compliance Specialist **,** to be located in eithe **r New Brunswick, New Jersey or Markham, Ontario Canada!** The following position will be a 12-month full time duration based role. 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/. [INSERT a few sentences to provide an overview of the job. Add selling points: What impact will this role have? What makes this job exciting?] **Key Responsibilities:** + Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to recommend product disposition (approve/reject). Authorize the release of inventory in the SAP system ensuring accurate quantities, material status and expiration date. + Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC). + 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. + 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. + 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. + 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). Build and maintain relationship with supply sites, wholesalers and key internal partners. + Lead and/or participate in other quality projects as required. **Qualifications** **Education:** + A minimum of Bachelors in Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry **Experience and Skills:** **Required:** + 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 or other Health Canada GMP-regulated industry experience within Quality Assurance. + Strong understanding of pharmaceutical production processes i.e. manufacturing, packaging, testing and process validation with pharmaceutical manufacturing experience preferred. **Preferred:** + Proficient/advanced user in SAP and able to provide support to other users. + Experience in a Quality Assurance Importer/Distributor role for the Canadian market. + Experience in leading quality investigations. **Other:** + This position is anticipated to have up to 10% travel Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 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. 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 . Johnson & Johnson is currently recruiting for a Senior Quality Release Compliance Specialist **,** to be located in eithe **r New Brunswick, New Jersey or Markham, Ontario Canada!** The following position will be a 12-month full time duration based role. 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/. [INSERT a few sentences to provide an overview of the job. Add selling points: What impact will this role have? What makes this job exciting?] **Key Responsibilities:** + Review and assess analytical, manufacturing and packaging documentation for finished products to ensure compliance to requirements/marketing authorization to recommend product disposition (approve/reject). Authorize the release of inventory in the SAP system ensuring accurate quantities, material status and expiration date. + Evaluate changes to master production documentation to ensure alignment to marketing authorization (in collaboration with RA CMC). + 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. + 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. + 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. + 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). Build and maintain relationship with supply sites, wholesalers and key internal partners. + Lead and/or participate in other quality projects as required. **Qualifications** **Education:** + A minimum of Bachelors in Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry **Experience and Skills:** **Required:** + 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 or other Health Canada GMP-regulated industry experience within Quality Assurance. + Strong understanding of pharmaceutical production processes i.e. manufacturing, packaging, testing and process validation with pharmaceutical manufacturing experience preferred. **Preferred:** + Proficient/advanced user in SAP and able to provide support to other users. + Experience in a Quality Assurance Importer/Distributor role for the Canadian market. + Experience in leading quality investigations. **Other:** + This position is anticipated to have up to 10% travel Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 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. 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 .