Quality Assurance Manager

3 weeks ago

Richmond Hill, Canada RxSource Full time $24 - $27
Company Overview:
At RxSource, our purpose is to improve the lives of patients. We accomplish this by offering Clinical Trial Supply Chain Services and Pharmaceutical Procurement globally. With offices in Canada, the USA, and Ireland, we deliver tailored services to Pharmaceutical Sponsors, Biotechs, and CROs. Our team and culture are our most valuable assets, embodying our core values in everything we do. We see our clients as partners, and their success is our success.

Position Summary:
The Quality Manager/RP - EU will oversee all activities within the Quality department across Europe, ensuring the implementation and ongoing development of the Quality Management Systems for all RxSource Limited divisions (Sourcing, Clinical Trial Services, Distribution, Medical Devices, and Regulatory Affairs). This role requires close collaboration with the global QA team to harmonize processes across our three RxSource sites.

As a pivotal leadership position, the ideal candidate will possess proven quality experience, strategic thinking, and strong communication and analytical skills to fulfill RxSource's vision, mission, and values.

Key Responsibilities:
  • Maintain compliance with all relevant EU regulations and legislative requirements.
  • Manage all Responsible Person (RP) tasks to ensure compliance.
  • Foster and embed a strong culture of quality within RxSource Limited.
  • Lead and develop the quality team at the Ireland location.
  • Collaborate with the global QA team to implement an Electronic Quality Management System and advance Integrated Management Systems.
  • Oversee all RP responsibilities and manage regulatory, customer, and vendor inspections.
  • Ensure the implementation and maintenance of initial and continuous training programs across all divisions.
  • Manage the Change Control process, ensuring controlled implementation of all GxP-related changes according to relevant SOPs.
  • Review and approve Corrective and Preventive Actions (CAPA), including tracking, follow-up, and evaluating CAPA effectiveness.
  • Lead QA responsibilities under the Manufacture and Importation Authorization (MIA), including Qualified Person (QP) duties, ensuring the implementation of good manufacturing practices (GMP).
  • Oversee QA responsibilities for Packaging and Labelling activities, ensuring compliance and quality standards.
  • Conduct validation/qualification of GMP equipment, systems, and facilities.
  • Communicate frequently with all departments to ensure seamless information flow (QA, Logistics, Project Management, Sourcing, Purchasing, Operations, HR, and Regional Teams).

Experience, Skills, and Qualifications:
  • 3+ years of QA experience in clinical trials, pharmaceuticals, or medical devices.
  • Solid knowledge of European regulations and guidelines.
  • Diploma or degree from a recognized college or university or equivalent working experience.
  • Proficiency in MS Office Suite (Outlook, Word, Excel, PowerPoint, OneNote, Teams).
  • Supervisory experience preferred.
  • Experience with Electronic Quality Management Systems (e.g., TrackWise).
  • Professional-level grammar and excellent proofreading skills.
  • Excellent communication skills (verbal, written, listening, conveying messages).
  • Detail-oriented with solid decision-making skills.
  • Highly adaptable and flexible, embracing teamwork while also working independently.
  • Experience working with colleagues across different global time zones.
  • Willingness and flexibility to travel as required.

Benefits:
  • Competitive salary and performance-based bonuses.
  • Comprehensive health, dental, and vision insurance.
  • Retirement savings plan with employer matching.
  • Generous paid time off (PTO) and holiday schedule.
  • Professional development and training opportunities.
  • Flexible work arrangements and remote work options.
  • Wellness programs and initiatives.
  • Travel expense reimbursement.
  • Collaborative and inclusive work environment.

Successful team members at RxSource are:
  • Patient Champions: Putting patients first and upholding strict ethical standards.
  • Achievers: Driving toward practical solutions.
  • Inspiring Individuals: Motivating excellence in themselves and those around them.

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