Job Description:

KNOWLEDGE AND SKILLS:

• Expertise in GxP Regulations, demonstrated working knowledge and practical application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). This includes deep familiarity with US, Canadian, and international/global regulatory requirements and associated guidance documents and standards across diverse modalities (e.g., small molecule, device, biologics, cell & gene therapy).
• Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence.
• Strong leadership and an innate ability to mentor, collaborate, and build relationships
• Direct experience with the GMP release of pharmaceutical products, with a preference for experience in Cell & Gene Therapy and/or Biologics products.
• Comprehensive Quality Systems Acumen, strong working knowledge and hands-on experience in key quality processes, including Product Complaints, Recalls, Inspection Readiness, and Event/Quality Issue Management.
• Highly adaptable and flexible, with the ability to thrive in a fast-paced environment and consistently act with urgency.
• Strong oral and written communication and interpersonal skills
• Experienced Lead Auditor
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
• Experience in GVP, GCP & GLP is desirable

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a biotech/Life sciences field and relevant GDP & GMP work
• Typically requires 6+ years of relevant industry experience in quality assurance and/or quality control in a biotechnology/regulated pharmaceutical environment.
  Pay Range:
  $60-$65/HR (dependent upson experience)
  Requisition Disclaimer:
  This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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THIS POSITION REQUIRES EXTENSIVE COLLABORATION AND INTERACTION WITH BOTH INTERNAL CROSS-FUNCTIONAL TEAMS AT VERTEX AND THE EXTERNAL NETWORK OF CONTRACT MANUFACTURING ORGANIZATIONS AND CONTRACT LABORATORIES. THE CORE OBJECTIVE IS TO ENSURE THAT ALL ACTIVITIES RELATED TO PRODUCT QUALITY AND DISTRIBUTION IN CANADA FULLY COMPLY WITH CGMP / GDP. FURTHERMORE, THIS ROLE IS CRUCIAL IN ENSURING THAT ALL NECESSARY QUALITY SYSTEMS ARE ROBUSTLY ESTABLISHED AND CONSISTENTLY MAINTAINED TO SUPPORT CANADIAN OPERATIONS.

This is a 24 month contract with chance to convert to full time role.
Hybrid. 3 days in office in Toronto.
This Position Reports to: Associate Director, Market Quality - Regional QA Lead

THE RESPONSIBILITIES OF THIS POSITION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:

• Ensure quality and compliance frameworks, guidance, and Canadian quality systems are in place to keep the products current with industry and health authority regulatory expectations, as well as Vertex’s QMS for products throughout the life cycle development.
• Ensure that Canadian quality system documents, SOPs, Quality Agreements, SMFs, are compliant, up to date and Write and review Quality Technical Agreements (TQAs) with CMO, suppliers and Customer.
• Manage the release and Batch certification of all the Vertex Canada Commercial products for sale to Canadian Market.
• Support the maintenance of the Vertex Canada Drug Establishment
• Support internal audits to ensure ongoing compliance and continued
• Support in managing the self-inspection audit program, including preparation of annual schedule and executing audit plans
• Support external audits of contract organizations, including Canadian warehouses and Canadian
• Work closely with the cross-functional partners to prepare for and support Health Canada inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
• Ensure that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements.
• Review Compliance documentation; Annual Stability Reports, Process Validation Documents, Unique ID certification and Alternate Retention Sample Certification
• Works collaboratively with the Vertex team in Quality, Regulatory Affairs, Supply Chain, Manufacturing and Commercial organizations to effectively execute tasks and to participate in projects representing the Vertex Canada affiliate
• Work with cross-functional partners for the risk identification, resolution of issues, OOS, and risk /gap mitigation
• Monitoring and reporting quality performance indicators to management and taking leadership in the performance of Quality Management Reviews
• Ensure all events, CAPA and Changes are appropriately documented and in line with the principle of Risk
• Ensure that initial and continuous training programs are implemented and maintained for relevant Vertex Canada
• Perform products Recall in Canada and conduct annual Mock Recall as per Global schedule
• Ensure that relevant customer complaints are dealt with effectively
• Provide global support as a Subject Matter Expert for many Global projects
• Approve any subcontracted activities which may impact GDP
• Ensure that any additional requirements imposed on certain products by national law are adhered to
• Ensure adherence to the quality roles and responsibilities stipulated within the most recent Pharmacovigilance Agreement executed by Vertex Inc Boston and Vertex Canada.
• The successful candidate will also provide flexible support to the hiring manager on various ad-hoc tasks and special projects as needed, contributing to the broader team objectives.