Quality Management Systems Associate

About the Role

The Quality Management System Associate is responsible for administering and maintaining the Master Control system to support compliance across GxP (GCP, GLP, and GMP) environments. This role ensures the system operates in alignment with global regulatory, privacy, ethics, and compliance requirements, facilitating proper documentation, version control, and traceability. The individual will collaborate with Quality Assurance to uphold system integrity, provide cross-departmental support to users, and ensure the system is effectively utilized to meet organizational objectives.

• System Administration and Maintenance:
  Administer and maintain the Master Control system to support GxP compliance, ensuring its effective operation and alignment with global regulatory, privacy, ethics, and compliance requirements.
• Issue Management and Provider
  
  Collaboration:
  
  Manage and resolve software issues, coordinating with the Master Control service provider to ensure timely resolutions and minimal disruptions.
• Application Updates:
  Stay informed about updates to the Master Control application, assess their relevance, and implement necessary changes to maintain optimal system performance and compliance.
• Employee and IT Resource Support:
  Serve as a resource for employees and the IT team, providing expertise, guidance, and technical support related to the Master Control system.
• Skills and Technology Advancement:
  Continuously update personal skills, stay informed on technological advancements, and perform a technical-level watch to maintain expertise in system management.
• Documentation and Compliance:
  Oversee proper documentation practices and version control within the Master Control system to ensure compliance with global regulatory standards and organizational policies.
• Audit and Inspection Expertise:
  Provide subject‑matter expertise during internal audits, external inspections, and audits, addressing questions related to the Master Control system and compliance practices.
• Cross‑Departmental
  
  Collaboration:
  
  Offer training, guidance, and support to users across departments, ensuring effective utilization of the Master Control system and fostering operational efficiency.
• IT and QA Partnership:
  Collaborate with Quality Assurance and IT to validate system integrity, support regulatory compliance, and align with organizational quality objectives.
• Workload Management:
  Handle multiple assignments simultaneously, effectively prioritize tasks, and meet strict deadlines while maintaining high standards of accuracy and efficiency.
• Business Relationship Development:
  Build and maintain strong relationships with internal stakeholders, the Master Control service provider, and external partners to ensure seamless operations and continuous improvement.
• Continuous Improvement:
  Identify and implement opportunities for system enhancements, process efficiencies, and compliance improvements to strengthen organizational performance.

• Bachelor’s degree, preferred.
• Ability to read and interpret documents such as operating instructions and technical procedure manuals.
• Ability to write routine reports, standard operating procedures, and basic business correspondence.
• Ability to speak effectively before groups of customers or employees of the organization, sponsors, participants, vendors, and monitors.
• Ability to work effectively in geographically dispersed cross‑functional teams.
• Excellent organizational, interpersonal, and leadership/teamwork abilities.
• Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner.
• Proficient experience with Master Control (1–4years) and understanding of Quality in the pharmaceutical/health‑care industry, preferred.
• Proficient knowledge of GxPs, regulatory, privacy, and compliance requirements.
• Good problem‑solving skills and the ability to make decisions.
• Project Management or Computer System Validation experience, preferred, or an equivalent combination of education and experience.

Salary range: $47,000 – $90,000 (varies by experience, education, location, and market data).

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences is an equal‑opportunity employer committed to diversity and inclusion. We aim to attract, develop, and retain highly talented employees from diverse backgrounds. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or any other protected class under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.