Associate Director, Regional QA Lead

2 weeks ago

Toronto, Canada Vertex Pharmaceuticals Full time

Job Description

General position summary:
This Position Reports to: Director, Market Quality

Key Responsibilities:
NA Regional activities:

- In cooperation with International QA teams, establish and maintain corporate quality objectives, actively promote an effective quality management system (QMS).
- Provide strategic guidance for and facilitate ongoing maintenance of processes and supporting systems.
- Act as the key liaison with Regional Business Partners in International Supply Chain and Commercial and provide strategic direction and alignment with business needs.
- Identify, assess and communicate mitigation plans for the risks determined within NA region.
- Lead regional QMS harmonisation initiatives and support business partners from the QA perspective.
- Support geographical expansion activities to ensure that Quality related actions are planned into projects and completed in line with commitments.
- Oversight and maintenance of the local Drug Establishment License.
- Ensure documented system is in place to support GxP compliance management both internally and externally, with all manufacturers and third parties to whom activities are delegated.
- Maintain oversight of outsourced activities and associated quality technical agreements.
- Ensure close partnership and alignment with other QA teams within Vertex in relation to product launch (process development, alignment on roles & responsibilities etc) in ensuring clear QA representation within NA affiliates.
- Support product recall and mock recall operations for Vertex NA sites and where acting as RP
- Act as the ‘go-to’ QA Subject Matter Expert.
- Maintain QA oversight of Named Patient Supply and Managed Access programs.
- Ensure QA oversight in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
- Build effective relationships with distribution QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
- Assess the impact and approve deviations, CAPAs and Change Control related to QMS.
- In collaboration with supply chain, ensure that supply chain maps are maintained for all distribution channels.
- Manage internal audits and support external audit scheduling, scope and other qualification activities.
- Perform risk assessments relating to Distribution Partner activities.

Vertex Canada Activities:

- Act as deputy RP on behalf of Vertex Canada in accordance with Drug Establishment License requirements. Work in partnership with other RPs and QA Specialist to ensure that Vertex Canada operations are in compliance with local requirements:

- Has responsibility for ensuring overall compliance with regulatory requirements and guidelines as relates to product disposition, product stability, Events Management, and Operational Quality functions for in-house manufacture, testing laboratories and storage.
- Directs quality activities relating to approval and rejection of procedures and specifications impacting the identity, strength, quality and purity of drug product
- Responsible for final approval of product specifications and product monographs
- Establishes Quality Agreement strategy with Canadian CMOs and GxP Vendors, and have approval of Quality Agreements
- Ensures overall program for commercial product complaint management and post marketing adverse event reporting are robust and compliant with Canadian regulations and guidelines
- Ensure Vertex Canada licence accurately reflect the current operations and vary licences as necessary.
- Ensure operational relationship is maintained with the Market Authoirzation Holder and with any pharmaceutical supplier.
- Organise and supervise the operations of batch monitoring and withdrawal, distribution, import and export of Finished Drug Products, as well as corresponding storage operations:

- Ensure the conditions of transport guarantee proper conservation, integrity and safety of these medicinal products
- Ensure that the safety devices have been affixed to the packaging
- Report any suspected or falsified product to Health Canada
- Act as the point of contact with Canadian Health Authorities. Ensure relevant stakeholder involvement and timely correspondence.
- Lead the affiliate Management Reviews for Vertex Canada and support affiliate Management reviews within NA region.
- Participate in quality escalation meetings providing input as the RP for Canada and where required, notify Health authorities of Quality Defects.
- Plan and host Regulatory inspections, providing front and backroom inspection support and leading post inspection follow-up with responses and CAPAs
- Monitor, assess the impact and communicate Regulatory Intelligence information
- Maintain knowledge of Good Distribution Practice
- Ensure that technical product complaints are managed
- Approve applicable GxP documentation and SOPs and management of authorised activities
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