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 Global Document Control Manager is responsible for the overall leadership of the document control functions within the Quality Assurance group. The manager will manage the life cycle of controlled documents ensuring regulatory requirements are met and leading continuous improvement initiatives. The Document Control function supports both the GMP and commercial operations. This person will manage eQMS processes and monitor compliance due dates for the global Medexus workforce. Other activities may include compiling of data for annual product quality reviews and other administrative support as needed by the Quality Assurance or Operations team.

· Lead all Document Control activities to ensure compliance with regulatory, quality, and company standards.

· Manage the lifecycle of controlled documents, including SOPs, forms, templates, and work instructions, within the electronic Quality Management System (eQMS).

· Assess and optimize existing document control systems; implement harmonization strategies across departments and functions.

· Collaborate with SMEs to develop and revise business procedures aligned with current regulations and industry best practices.

· Serve as system administrator for the eQMS. Lead system implementation, maintenance, upgrades, and associated validation efforts.

· Maintain document review schedules to ensure procedures remain current, accurate, and reflective of actual practices.

· Enhance records management practices, including secure storage, retention, retrieval, and destruction of GxP documents.

· Drive continuous improvement in document control processes, including system integrations and cross-functional harmonization.

· Lead information management and integration efforts related to M&A activities.

· Provide audit and inspection support by ensuring timely access to accurate and compliant documentation.

· Execute and support GxP training programs by identifying learning needs, coordinating with stakeholders, and delivering effective training.

· Develop and manage training content to support Quality and GxP compliance initiatives.

· Lead documentation and training projects that advance strategic GxP and quality system goals.

· Compile and maintain Annual Product Quality Review (APQR) reports for U.S. and Canadian markets.

· Track and report quality system metrics to support continuous improvement initiatives

· Bachelor’s degree in science or a related field.

· 8+ years of experience in QA Document Control within the pharmaceutical or biotechnology industry.

· Previous experience as a Super User or System Administrator for an eQMS in a regulated industry.

· Strong knowledge of U.S. FDA and Health Canada GxP and regulatory requirements.

· Demonstrated experience supporting or leading regulatory audits and inspections.

· In-depth knowledge of electronic Quality Management Systems (eQMS), including system administration and validation.

· Advanced proficiency in Microsoft Word, Excel, and PowerPoint

· Familiarity with project management tools such as Monday.com and Smartsheet.

· Experience in adult learning or training program development is preferred.

· Experience leveraging AI tools for document management or content generation is an asset.

· Location: Remote position located in US or Canada

· Travel: up to 20%

· Compensation: $100,000- $125,000

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.