Senior Director, RDQA, Operational Quality, Medical Device and Combination Therapies

Job Description

General position summary: 

The Sr. Director, RDQA Medical Device and Combination therapies 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 Medica 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, RDQA 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 medial 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 of RDQA Medical Device Operational Quality will be one who has 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.      

This position reports directly to the Head of RDQA.

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.

• Develop RDQA Goals and strategies for the biologics, device and combination therapy programs within the RDQA function.
• Collaborate with RDQA Regulatory Intelligence to manage the regulatory compliance intelligence within the biologics, device and combination therapy function.
• Maintain and gather industry knowledge and best practices.
• Liaise with key stakeholders and business partners to promote high level of quality and consistency across and within programs in medical device and combination therapies.
• Represent RDQA on GCP/GLP Regulatory interactions and build a strong vendor management and inspection readiness function for medical device and combination therapies
• Partner with QA and business leadership for coordination and alignment in ensuring overall quality and compliance of internal operations and applicable vendors.
• Participate in Quality Program Updates and lead in Operational Quality Leadership / Governance Teams responsible for assessing GCP compliance risk areas (internal and external) and develop and implement risk mitigation measures; Lead Stage Gate Reviews for advancing trials thorough clinical phases for assigned programs.  Responsible for identifying, evaluating, and mitigating risk collaboratively with business partners to understand and communicate quality risks as applicable to Clinical Programs as well as propose appropriate remedial, corrective and /or preventive actions
• Provide guidance, interpretation and information on regulations, standards and quality systems to GCP functional areas responsible for clinical trial execution of medical device and combination therapy programs.
• Develop and measure key quality metrics to ensure consistent quality standards relating to GCP activities to drive proactive and predictive quality improvements.
• Ensure inspection readiness for assigned medical device and combination therapy Programs.
• To drive process improvement, provide specialized knowledge and consultative guidance on medical device and combination therapies, GxP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated  medical device and combination therapies activities.
• Elevate staff, functional and organizational capabilities through the development of a comprehensive Medical Device and Combination Therapy Training Program and Center of Excellence with fit-for-purpose tools, templates, libraries, reference materials and intelligence to inform stakeholders with data driven insights and inferences.
• Participate in the evaluation and selection of GCP service providers.
• May provide functional area leadership and management, which includes Performance Management (goals, monitoring, reviews), Employee Learning and Development (Identification of training needs and support of aspirational goals, Talent Acquisition/ Recruiting/Interviewing/ selection, Onboarding/ Transition/Succession Planning, and Oversight of day-to-day execution
• May serve as GCP Quality Management System representative for Medical Device and Combination therapies.
• Participate in collaborative review of impacted controlled documentation related to Vertex Standards, SOPs, and Work Instructions
• Review and analyzes key Performance Indicator data and trends
• May participate on process improvement initiatives
• Provides QA review of protocols and participates on Operational Review Boards to identify strategic and operational risks and collaborates with Program and Study Quality Leads and teams in development of fit-for-purpose risk mitigation strategies related to the medical device portfolio and programs.
• Collaborates with Audit and Inspection Management teams to develop risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies; assess impact of audit finding and other identified compliance risks to subject safety, data integrity and business operations and escalates significant compliance risks

Minimum qualifications:

• Bachelor's/Masters degree in a scientific or allied health field (or equivalent degree)
• At least 15 years of GCP Operational QA experience in addition to 7+ years of management experience or the equivalent combination of education and experience in medical device and combination therapy trial execution and regulation.
• Preference to candidates with GLP and / or GVP experience in addition to the required GCP background
• Preference for candidates with a Legal, Privacy or Regulatory background, in addition to Quality, including prior experience working for a Health Authority

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.