Contract Auto Control Medical jobs

Company Bio

Medexus Pharmaceuticals Inc. is a leading specialty pharmaceutical company with a focus on the therapeutic areas of rheumatology, auto-immune disease, specialty oncology, allergy, and pediatric diseases. We provide market-leading prescription and over-the-counter brands to patients and healthcare professionals, which we believe greatly enhances quality of life and promotes a healthy lifestyle. We have a strong North American commercial platform, and we currently operate through two unique segments: Medexus Pharma Canada and Medexus Pharma USA. Innovation is a driving force for our company. As a result, we are continuously licensing and/or acquiring new products and solutions aimed at addressing the essential needs of consumers, patients, and healthcare partners.

The Senior Manager, Global Quality Assurance is responsible for the Quality Assurance oversight of the activities supporting manufacturing and product release at the Medexus Contract Manufacturing Organizations (CMOs). The manager will ensure that all Active Pharmaceutical Ingredients and Finished Products and processes meet the U.S. FDA, Health Canada, European Medicines Agency (EMA), and ICH (International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use) regulations and guidances for Drugs, Biologics and Medical Devices. This position will lead and oversee Product Release activities, Supplier Management, Risk Assessment, CAPA and Change Review Board teams and provide QA review of technical manufacturing documents. You will work collaboratively with Regulatory, Supply Chain, Technical Operations, and Document Control teams.

Key Responsibilities

• Manage the Medexus Quality Systems and ensure Medexus harmonization and compliance across all products in the key Quality Assurance activities including:
• Batch Record Review, Batch Disposition and Product Release to market
• Internal Change Control process, Nonconformance Investigation, CAPA, Annual Product Quality Review (APQR), Product Complaint Investigations and Design Control
• Lead Material Review Board, CAPA Review Board, Change Review Board, and Risk Assessment teams
• Lead and develop Global QA staff, ensuring operational excellence and effective quality oversight, regulatory compliance, and consistent product supply
• Build relationships with internal and external partners to ensure compliant quality systems
• Assist Global QA Team with the resolution of quality-related product issues
• Ensure Quality Assurance approval of Supplier GMP documentation, including Master Batch Records, Test Methods, Specifications and Design Characterization, Verification, and Validation activities
• Accountable for Internal Audits of GMP activities and External Audits by partners or regulatory authorities
• Track and report quality system metrics to support continuous improvement initiatives

Qualifications and Experience

• Bachelor’s or Master’s degree in a scientific discipline required
• 8+ years of progressive Quality Assurance experience within the pharmaceutical or biotechnology industry
• 4+ years of experience managing, coaching, and developing QA professionals
• Experience supporting biologic products is required; experience supporting cell therapies/other advanced therapies and small molecules is considered an asset
• Experience providing Quality Assurance oversight across the product lifecycle, including commercial manufacturing, technology transfers, product launches, post-approval changes, and lifecycle management
• Extensive experience with sponsor oversight of CMOs, including batch review and disposition, deviations, investigations, CAPA, change control, supplier quality management, annual product reviews, quality agreements, and internal and external audits
• Extensive knowledge of U.S. FDA, Health Canada, EMA, and ICH regulatory requirements and their application to biologics products is required
• Demonstrated experience leading CAPA and Change Review Boards
• Demonstrated ability to lead leading complex, cross-functional quality programs, continuous improvement initiatives, simplify quality systems, and implement pragmatic, risk-based quality processes
• Demonstrated experience leading regulatory inspection readiness and supporting inspections by FDA, Health Canada, EMA, and other global regulatory authorities
• Experience evaluating quality risks associated with licensing, acquisitions, product transfers, and integration activities is considered an asset
• Strong analytical, problem-solving, and decision-making skills
• Advanced proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with project management tools such as Monday.com and Smartsheet and data analytics tools such as JMP is preferred

Additional Information

• Location: Remote position located in US or Canada
• Travel: up to 25%
• Compensation: $140,000 - $180,000

We recognize that experience comes in many forms. Even if your background or compensation expectations don’t exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus.

Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications.