Regulatory Affairs and Quality Specialist

4 weeks ago

Mississauga ON, Canada Juno Pharmaceuticals Full time

The Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of activities relating to establishment licensing, batch record review, product dispositions, vendor qualification, self-inspections, complaints, deviations, CAPAs, SOP writing, change control, process validation, analytical method validation/transfer, department KPI management, and the fulfilment of post market commitments.
The Quality & Compliance Specialist must act as a positive influence toward quality awareness throughout the organization. The position requires detailed knowledge of Health Canada Food and Drugs Act, regulations and guidance documents. Experience in the quality and commercial requirements of sterile drug products used in a hospital setting for the provincial and territory health care programs in Canada is an asset. The role requires analytical thinking, evidence based decision making skills and exceptional time management abilities to progress multiple concurrent projects within established timelines.
Support the digital transformation of the quality management system
• Lead the enhancement and maintenance of training materials to provide effective SOP and GMP training to Juno’s staff as needed.
• Develop strategies to achieve method transfers and validations at Juno’s local labs to facilitate product launches and confirmatory testing.
• Perform dispositions of drug products to the Canadian market ensuring compliance to Health Canada regulations and Juno’s SOPs.
• Review Annual Product Quality Review and Yearly Biologic Product Reviews generated by Juno’s quality assurance department and partners to ensure compliance to the marketing authorization.
• Document, report, investigate and respond to product complaints.
• Support the vendor qualification program by performing onsite, virtual and/or desk-based audits of JPC’s GMP service providers.
• Support the quality oversight of pharmaceutical manufacturing, packaging/labelling and testing deviations/non-conformance investigations and CAPA implementation at CMO’s and internally.
• Identify non-conformances, initiate investigations and lead the impact assessments to support process control and product dispositions.
• Lead the maintenance of JPC’s drug establishment licence foreign building annex, Table A and GMP evidence of foreign buildings.
• Perform quality assurance impact assessment for internal and third-party related change control records.
• Support in any regulatory or third party audit of JPC as required.
• Proactively monitor USP and BP for monograph updates and prepare for implementation
• Perform additional duties as assigned by the Manager, Quality.
Post-Graduate Certification in Regulatory Affairs and Quality Assurance preferred.
• Detailed knowledge of Canadian Food and Drugs Act and Regulations, Health Canada guidance documents, ICH guidance documents, GMPs and other relevant guideline with focus in sterile injectables used in a hospital setting.
• Minimum 5 years relevant Canadian experience in a pharmaceutical quality assurance or compliance role with external audit experience.
• Proactive with a high degree of self-discipline, drive and ability to work remotely or on-site with minimum supervision.
• Excellent in Microsoft Office Suite and Adobe Acrobat.
This job description for the Quality & Compliance Specialist outlines the primary responsibilities of the role and should not be considered a detailed description of all requirements that may be inherent in the job. The position is a hybrid position of remote work and in-office attendance with some domestic and international travel required to support the audit program as needed.

  • Quality Assurance

    1 month ago

    Mississauga, Canada Hansamed Ltd. Full time

    **Quality Assurance & Regulatory Affairs Specialist position** HANSAmed is a specialty Cell-Tissue-Organs, Medical Device, and pharmaceutical distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed...

  • Regulatory Affairs Specialist

    1 day ago

    Mississauga, Canada M&M Food Market Full time

    We are looking for our next Regulatory Affairs Specialist. Could it be you? Reporting to the Regulatory Affairs Manager, the Specialist, Regulatory Affairs ensures effective implementation and management of the regulatory affairs systems, programs and procedures for the business. You'll advise and provide regulatory guidance to internal business units on...

  • Regulatory Affairs Specialist

    4 weeks ago

    Kitchener, ON, Canada Vena Medical Full time

    Vena Medical - Regulatory Affairs Specialist   About Us: Vena Medical is at the forefront of revolutionizing stroke treatment through cutting-edge catheter-based technologies. Our commitment to innovation has inspired our flagship products, the Vena MicroAngioscope™️ and the Vena Balloon Distal Access Catheter™️. These pioneering technologies...

  • Quality Assurance and Regulatory Affairs Associate

    6 days ago

    Mississauga, Canada Septa Pharmaceuticals Inc. Full time

    Septa Pharma Inc., is proudly a Canadian owned and operated Pharmaceutical Company based in Mississauga, Ontario. Our Mission is to provide quality pharmaceutical and healthcare products to advance and nourish the quality of life in domestic and global markets. We are excited to announce the opening for the position of **Quality Assurance and Regulatory...

  • Quality Assurance and Regulatory Affairs Associate

    4 weeks ago

    Mississauga, Canada Septa Pharmaceuticals Inc. Full time

    Septa Pharma Inc., is proudly a Canadian owned and operated Pharmaceutical Company based in Mississauga, Ontario. Our Mission is to provide quality pharmaceutical and healthcare products to advance and nourish the quality of life in domestic and global markets. We are excited to announce the opening for the position of **Quality Assurance and Regulatory...

  • Quality Assurance

    1 week ago

    Kitchener, ON, Canada Intellijoint Surgical Inc Full time

    Quality Assurance & Regulatory Affairs Analyst Contribute towards safe and effective products at a fast-growing medical technology company! Type of Position: Full Time Location: Kitchener HQ – In office presence required 3-days per week RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development...

  • Regulatory Affairs Specialist

    1 month ago

    Mississauga, Canada Profound Medical Full time

    Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic,...

  • Regulatory & Scientific Affairs Specialist

    4 weeks ago

    Cambridge, ON, Canada Nutrablend Foods Full time

    Meet Nutrablend Foods Nutrablend Foods is one of the largest custom manufacturers of specialized health nutrition powder products in North America, powered by an experienced team with a passion to help customers hustle and thrive. With over 20 years working with some of the top Sports Nutrition brands around the world, our experience supports our...

  • Medical Device

    4 weeks ago

    Mississauga, Canada Diploma Healthcare Group Full time

    The Company is part of the Diploma Healthcare Group (DHG) which is a group of specialized medical device distribution companies operating in Canada, Australia, New Zealand and Ireland. DHG is owned by Diploma PLC, a public company traded on the London Stock Exchange with a market cap in excess of £1.1B. **Somagen Diagnostics Inc.** was founded +30 years...

  • Regulatory Affairs Manager

    1 week ago

    Mississauga, ON, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...

  • Regulatory Affairs Manager

    1 week ago

    Mississauga, ON, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Canada ct bakery Full time

    **Duties** - The primary focus of the role is to ensure the accuracy of the regulatory information in our databases for ingredients, allergens, formulas and labels for Canada US markets - Issuance of label information documents that comply with the regulations; and regulatory compliance of final product labels including product naming, ingredients, nutrition...

  • Manager, Regulatory Affairs

    6 days ago

    Mississauga, Canada Trillium Health Partners Full time

    **Job Description**: **Position**:Manager, Regulatory Affairs **Status**:Full Time **Department**:Professional Practice **Posted Date**:Monday July 10th, 2023 - July 31st, 2023 11:59 PM EDT **Salary Band**: $96,200 - $144,350 (salary band placement commensurate with experience) *** A New Kind of Health Care for a Healthier Community. That’s our...

  • Regulatory Affairs Manager

    7 days ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association...

  • Regulatory Affairs Manager

    1 week ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association...

  • Regulatory Affairs Operations Associate

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Regulatory Affairs Manager

    7 days ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    1 week ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, Canada The Portage Group Full time

    Company DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...