Title: Quality Assurance and Regulatory Affairs Manager
Location: Burnaby, British Columbia, Canada
- Use your science background to make a positive impact in the lives of others!
- Competitive remuneration and benefits package!
Medipure’s mission is to revolutionize drug discovery and bring innovative and safe medication for the treatment of pain, anxiety and skin disorders. We bring novel prescription medicines to market, providing patients with serious conditions valuable solutions that improve quality of life through the development of safe and effective endocannabinoid-based therapeutics.
Through rapid cost-effective product development, by addressing market needs, and establishing strategic partnerships, we seek to maximize the value of our products and provide innovative treatments for targeted diseases. For information, please visit our website.
About the Opportunity
Medipure is rapidly growing and we have an exciting opportunity for a Quality Assurance & Regulatory Affairs Manager to join our team at our R&D facility in Burnaby (B.C., Canada) on a full-time basis.
This position is ideal for someone who has experience in quality management and regulatory affairs in the pharmaceutical industry and wishes to learn and engage in exciting drug discovery projects and development company.
The duties will cover the areas of regulatory affairs and quality assurance.
1. Principle Accountabilities
Reporting to the Chief Technology Officer the incumbent will be working within a team to preform a variety of Quality Assurance related function to contribute to the creation and implementation of the QMS programme at Medipure.
2. Quality assurance:
- Prepares, reviews and implements the procedures, policies and QMS manuals to get facility accreditation (GLP, GMP, and ISO9001).
- Set up and manage a document control system, ensuring all internal filing requirements are maintained properly.
- Drafts, revises and implements company procedures, policies and quality documents to ensure compliance across all departments.
- Write, review and evaluate a variety of foundational QA SOP’s including but not limited to activities involving change control, document management, personnel training, deviation reporting, CAPA, vendor qualification and self-inspections.
- Trains all personnel with QC, QA principles, GMP and SOP training initiatives.
- Performs all QA functions including, but not limited to: Batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.
- Prepares analytical reports and Certificate of Analysis (CoA) for R&D products.
- Ensures that the company adheres to GMP, GLP, ISO 9001 and applicable acts/regulations.
- Reviews production and laboratory records, assisting in internal audits and self-inspections.
- Conducts external audits for suppliers and service providers.
- Performs equipment and instrument calibration/validation and preventive maintenance duties as required.
- Perform other tasks as needed.
- Ensures that The Company’s research programs and products are compliant with the regulations, acts and associated policies of the Canadian federal and/or provincial government. Notably: CDSA (Controlled Drugs and Substances Act), NCR (Narcotic Control Regulations)
- Maintains current regulatory knowledge for all relevant domestic and/or international standards, applying appropriate implementation strategies where required
- Prepares and reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Technical Files, site licenses/registrations, Drug Master Files (DMFs) and risk analysis impact determinations
- Reviews documentation for approval in the local/global transport and distribution of R&D materials, resolving compliance issues when necessary
- Prepares regulatory submissions, inventory reports, and coordination of responses to Health Canada
- Provides real-time compliance support to the R&D team
- Master’s or bachelor’s degree or diploma in relevant degree areas, including Biochemistry, biotechnology, chemical, and physical sciences, life sciences, pharmacology or pharmacy.
- Minimum 5 years’ experience in quality assurance, regulatory affairs, compliance, and document management in the biotech industry or equivalent.
- Experience in creation and implementation of QMS program
- Experience in an environment adhering to federal governmental regulation (i.e.: Health Canada, FDA, etc.) is an asset.
- Strong GMP pharma/QPIC experience is preferred.
- Experience in document control and management is an asset
- Knowledge of country-specific regulatory requirements is an asset. Experience with preparing regulatory submissions is an asset.
- Understanding of both legal and scientific matters. Proven ability to grasp new concepts quickly. Excellent technical and scientific report writing. Strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures, and processes. Excellent communication skills. Analytical, methodical and diligent with outstanding planning abilities.
- Prior experience interacting with auditors and regulators.
- Familiarity with CDSA and NCR and risk management controls.
- Strong computer, scientific, and organizational skills
If you want to further develop your skills and build a long-term career with a growing company – Apply Today!
About the Benefits
Upon joining Medipure you will be welcomed into a dynamic and multicultural team. In exchange for your hard work and dedication, you will receive a competitive annual salary plus a comprehensive benefits package.
And that's not all! When you join Medipure, you will have the ability to define your own career path while working with an engaged and excited team.