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 DESCRIPTION:

Johnson and Johnson is recruiting for a CQ Product Compliance Specialist based in Toronto, Canada! This is a fixed term, expected to last 18 months.
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
On this team, we provide end to end quality oversight of GMP laboratories responsible for analytical testing of commercial and clinical products in the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

EDUCATION:

• A minimum of a B.SC. in Science with preference to Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry.

• 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 Johnson & Johnson Innovative Medicine Canada.
• Ensure Purchasing Controls processes are effectively implemented and managed (e.g. supplier audit plan and monitoring, negotiation and implementation of quality agreements, maintenance of Approved Distributor List and Approved Supplier List and related documents in e-QMS)
• 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.
• 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).
• Support new product launches and product site transfers ensuring that all Master Records and release specifications/documentation meet Health Canada marketing authorizations.
• Support self-inspections and support HC GMP/DEL/MDEL/Controlled Substances & Corporate audits.
• 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.
• 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).
• Receive and perform intake of product complaints (PQC, and combined AE/PQC) from any source into the Quality Complaint Handling System in accordance with current regulation and corporate procedures.
• Monitor complaints entered into the Quality Complaint Handling System to ensure all required outreach activities/task actions are completed. Follow-up with customers, as required.
• Ensure field samples are retrieved in a timely manner and complete timely follow-up of field sample return.
• Act as Alternate Qualified Person in Charge (AQPIC).
• Participate in other quality projects/activities as required.