Senior Director, R&D Quality, Medical Device and Combination Therapies
Vertex Pharmaceuticals Incorporated | |
United States, Massachusetts, Boston | |
50 Northern Avenue (Show on map) | |
Oct 04, 2024 | |
Job Description The Sr. Director, R&D Quality, Medical Device and Combination therapies will report to the Head of R&D Quality and will ensure operational delivery and execution and provide strategic direction and oversight of the device and combination therapy programs within Research and Development QA (RDQA) from the (pre)clinical phases of the product lifecycle through to submission and approval of designated programs across modalities, biologics, medical devices and combination therapies. This role will establish processes and capabilities for effective and proactive quality oversight and risk management across respective product/therapeutic program area(s) (e.g. Type 1 Diabetes). This individual will support the Vertex business and Quality Assurance Biologics and Device functions by serving as the resident RDQA Medical Device and combination therapy expert, supporting the appropriate global and local QMS in establishing operational and quality excellence and a constant state of inspection readiness for both products and device across the Vertex portfolio. This individual will provide strategic oversight and leadership for Quality Management Reviews and spearhead the design and development of medical device and combination therapy fit-for-purpose program level Quality Plans, ensuring transparency for gaining insights regarding effectiveness of risk mitigation strategies/controls, proactive and sustainable compliance. This individual will integrate end-to-end quality principles and review preparedness at key milestones in alignment with organizational and project milestones. The Sr. Director, R&D Quality, Medical Device and Combination therapies leader will foster strong collaboration and partnership with external and internal stakeholders; international leadership teams, business stakeholders, strategic alliances/collaborators and regulatory agencies globally. This candidate will ensure alignment with Quality leadership and teams (e.g. audit, vendor management) in development of integrated strategies for portfolio scalability, international expansions and sustained compliance across all affiliates, process and vendor oversight and assurance. This individual will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging medical device, biologics and combination therapy industry trends and best practices (e.g. operating models, regulatory requirements) to elevate RDQA capabilities in this space as well as to facilitate maximum value to evaluation of the health of the quality system and identification of cross functional risks that will require assessment by the GXP functional areas. The Sr. Director, R&D Quality, Medical Device and Combination therapies will have demonstrated success in understanding and establishing of affiliate business units and building out of core competencies and capabilities within the quality organization (E.g. Medical Device Operational Center of Excellence) that supports the business' medical device strategy that assures fit-for-purpose and compliant outcomes and operational excellence. This candidate will perform advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex device and combo trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System. These activities include the operational quality oversight of the clinical development programs in our Medical Device, Biologics and Combination therapy Areas. These may include, Program and Study level quality risk assessment, inspection readiness activities, quality event identification and mitigation with participation in escalation activities as required. Key capabilities for this position are the ability to lead and influence Program Teams to ensure a high level of compliance, distill complex risks and issues to meaningful and easily understood updates to senior leadership, strong collaborator with good judgement and business acumen, willing to be a mentor / coach to more junior Quality Associates, partner across Vertex Quality to understand critical touch points across the Program, and have meaningful input to creating metrics and KPIs for Program updates with the ultimate goal of building out a custom Center of Excellence Framework and Training Program that elevates RDQA capabilities in the medical device space. Key Responsibilities: The responsibilities of this position may include, but are not limited to, the following: Serve as a key technical resource for the GCP clinical execution function with responsibility of assuring quality risk management/ mitigation and adequacy and compliance with GCP regulatory requirements and guidance to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
Minimum qualifications:
Flex Designation: Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex 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 |