Job Description

General position summary:Associate Director, Regional QA Lead (NA) is a leader within International Quality organization who holds responsibility in ensuring quality compliance in two key areas: Regional QA activities that apply to North America (NA) Vertex Affiliates and GxP principles and standards that Vertex Canada must meet as DEL holder. This position holder has an oversight of the distribution network and will lead quality oversight initiatives associated with NA region. Associate Director, Regional QA Lead will also act as the Responsible Person at Vertex Canada ensuring ongoing maintenance of the licenses, leading regulatory inspections, and supporting International Quality in wider regional or global projects.This Position Reports to: Director, Market QualityKey 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 \xe2\x80\x98go-to\xe2\x80\x99 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
• Ensure that customers and suppliers are approved
• Approve any subcontracting that may impact GDP
• Ensure that self-inspections are performed at appropriate regular intervals following a pre-arranged program and that necessary corrective measures are put in place.
• Decide on the final disposition of returned, rejected, recalled or falsified medicines, including the approval of returns to saleable stock.
• Release returned products to saleable stock
• Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Remain continuously contactable and available to attend the site as required
• Ensure procedures are in place outlining delegated activities
• Responsible for oversight of PV as it pertains to the Canadian market
• Ensures the quality role and responsibilities identified in the most current Pharmacovigilance Agreement between Vertex Boston and Vertex Canada is complied with
• Support in New Product Launch activities in Canada.
• Provide QA support during business reviews with partners.

KEY TECHNICAL KNOWLEDGE, SKILLS AND COMPETENCIES:

• Strong leadership skills with the ability to lead a team to thrive in a fast paced, evolving environment.
• Able to leverage knowledge of organisational objectives, goals and mission to shape QA initiatives.
• Takes risk-based approaches to create a variety of cost-effective solutions that ensure that compliance and business requirements are optimized.
• Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness.
• Ability to recognize risks and issues impacting the budget, and develop recommendations for mitigation across scope of responsibility
• Develop and apply creative solutions that meet demands of the function
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
• Work cross-functionally with all levels to foster exceptional collaboration.
• Root Cause Analysis tools/methodology
• Sense of urgency- ability to act quickly/escalation process/transparency
• Attention to detail
• Fluency in verbal and written English

Minimum qualifications:Bachelor\xe2\x80\x99s degree in a scientific or allied health field (or equivalent degree) and relevant work experience, or relevant comparable background.Meets the requirements for the person in charge of the quality department as per Health Canada Guidelines GUI-0001, C.02.006.Preferred Qualifications:

• Degree in pharmacy, chemistry, medicine, biology or a related life science
• GDP & GMP work experience, or relevant comparable background.
• Experienced Lead Auditor
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Company InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person\'s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Vertex Pharmaceuticals