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Senior Director - Quality Data, Digital Systems & Compliance

Vertex Pharmaceuticals · Boston, MA · 1 mo ago
Hybrid$228k–$342k/yrFull-time
We need to output HTML fragment with sections: About the role (General Position Summary), Responsibilities (Key Responsibilities), Requirements (Education level and/or relevant experience(s) and Required: In-depth knowledge...), Benefits (the paragraph about benefits), Pay (Pay Range), Schedule (Flex Designation). Also maybe Qualifications? The posting includes "Required: Education level..." and "Required: In-depth knowledge...". Could combine into Requirements. Also "Qualifications" maybe not separate. We'll include sections: About the role, Responsibilities, Requirements, Benefits, Pay, Schedule. We must not repeat job title as heading. No Job ID. Remove boilerplate: EEO, E-Verify, accommodation request, etc. Also remove "Company Information" maybe? It's boilerplate but includes description of Vertex; might be considered not substantive? It's generic company description; we can drop as it's not specific to role. Also remove "Disclosure Statement" maybe part of Pay? It's about pay range; we can keep Pay Range and maybe note bonus/equity but that's part of benefits? Actually it's about pay. We'll include Pay section with range and note about bonus/equity? The instruction: include section only when posting has real, specific content. Pay Range is specific. Also note about bonus/equity is part of total rewards; could be in Benefits. We'll keep Pay with range and maybe mention bonus/equity as part of Benefits? But better to keep Pay with range and note about bonus/equity as part of Benefits? The instruction: "Prefer a few substantive sections over many thin ones." Could combine Pay and Benefits? But they ask to use headings for Benefits, Pay, Schedule if present. We'll include each. We must not include filler like "commensurate with experience". Not present. We need to preserve all substantive information. So we need to include the General Position Summary text, the Key Responsibilities bullet points (but we need to convert to
  • ). The responsibilities are long paragraphs with colon headings; we can break each bullet as separate
  • . We'll need to parse. Let's extract sections: General Position Summary: paragraph(s) after "General Position Summary:" until "Key Responsibilities:". Key Responsibilities: list of items each starting with a bold heading? Actually text: "GxP Quality Data Governance and Data Integrity Leadership:Advance, scale and mature the enterprise GxP Data Governance framework, policies, standards, and procedures. Provide strategic leadership and direction to GxP Data Integrity program aligned with ALCOA+ principles and global regulatory expectations.Chair cross-functional data governance forums and ensure clear accountability for data ownership and stewardship." Then "Master Data Management (MDM) Leadership:" etc. We'll treat each heading as a separate
  • containing the sentences. We need to preserve all content; we can keep the heading text as part of li. Similarly for Requirements: "Education level and/or relevant experience(s): BS, MS, JD, MD, or PhD in a Life Sciences, Engineering, Information Systems, Computer Science, Quality discipline or equivalent. Fifteen (15) years relevant work experience with 7 years leadership supervisory role in a global organization. Operational/Quality experience (e.g., GMP, GCP, IT). Experience working across business/operational functions in a regulated environment and at an enterprise level preferred. Experience building sustainable and advanced data integrity, computer systems assurance strategies, advanced analytics, and data governance driving proactive quality management and digital/data insights enabled predictive models." Then "Required: In-depth knowledge in the following areas: Strategic leadership across data integrity/governance and Computer Systems Assurance (CSA/CSV) programs and operations, including data quality, master data management, metadata, and governance frameworksAdvanced analytics, business intelligence, risk management, and data-driven decision-making leadershipProven ability to lead digital transformation, organizational change, and process modernization initiatives. Exceptional cross-functional leadership, stakeholder engagement, and influencing skillsStrong governance, risk management, and inspection readiness experienceHighly collaborative and effective at building strong enterprise and cross-functional relationships; a strategic change leader who delivers results through influence, partnership, and leadership.Comfortable in a demanding, fast-paced, patient-focused environment with a start-up culture and evolving processes; flexible and able to adapt as business needs change.Hands-on, action-oriented leader willing to roll up their sleeves, with the flexibility to adapt to a start-up environment. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients." We can keep as paragraphs. Benefits: paragraph after "At Vertex, our Total Rewards offerings also include inclusive market-leading benefits..." until before "Flex Designation". We'll capture that. Pay: "Pay Range: $228,000 - $342,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law." We'll keep that. Schedule: "Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time." We'll keep that. Now produce HTML:

    About the role

    ...General Position Summary...

    Responsibilities

    • GxP Quality Data Governance and Data Integrity Leadership:Advance, scale and mature the enterprise GxP Data Governance framework, policies, standards, and procedures. Provide strategic leadership and direction to GxP Data Integrity program aligned with ALCOA+ principles and global regulatory expectations.Chair cross-functional data governance forums and ensure clear accountability for data ownership and stewardship.
    • Master Data Management (MDM) Leadership:Provide strategic direction and owns the model and oversight for quality-related master data across GxP functions.Embed the GxP MDM Model across the QMS with strategic leadership and championing data ownership, stewardship, for ensuring scalability, continuous improvement of master data quality and scalable lifecycle management processes.Provide strategic direction and govern data catalogs, business glossaries, data standards, and data lineage.
    • Data Quality Management Leadership and Strategic Direction:Define GxP enterprise data quality standards, metrics, controls, and monitoring processes.Embed and mature proactive data quality surveillance and remediation programs.Embed, scale and mature risk-based approaches for monitoring critical-to-quality data.Ensure data accuracy, completeness, consistency, traceability, and fitness for intended use
    • CSV/CSA & Computer Systems Quality Oversight: Provide strategic Quality oversight of computerized systems supporting GxP activities.Ensure compliance with 21 CFR Part 11, Annex 11, and global computerized systems requirements.Govern validation/assurance methodologies, lifecycle management, and periodic review processes.Partner with DTE, quality and business leadership and stakeholders on GxP-enabling implementation, upgrades, integrations, digital capabilities, and solutions.Maintain inspection readiness for computerized systems and data integrity controls.
    • Quality Analytics and Business IntelligencePartner with quality and business leadership to craft and refine the vision for quality data analytics and governance to provide real-time insight into GxP compliance, process performance and resource utilization.Set the strategic vision and drive development and maintenance of data models, reporting systems, data dashboards, descriptive, investigative and predictive analytics, and performance metrics to support quality delivery and organizational decision making.Define and drive a structured and nimble approach for ongoing and timely translation of data into
    • Quality Leadership, Enterprise Partnership, Change Management and Quality Culture Championship:Role models Quality Leadership, serving as a visible leader, advocating quality culture, and ensuring accountability, transparency, and integrity in how quality decisions are made and communicated across the enterprisePartner with QA leadership and enabling enterprise functions (e.g., Finance, Strategic Sourcing, Human Resources) in proactive management and strategic planning and translation into operating standards, inspection readiness, compliance and excellenceLead, develop, and mentor quality professionals to mature the capabilities and leadership needed to scale and transform the organization and QMS across a diverse portfolio of products, technologies, geographies, and evolving business needs. Serve as change agent for transformation initiatives, including digitization and advanced technology integration across the QMS

    Requirements

    Education level and/or relevant experience(s): BS, MS, JD, MD, or PhD in a Life Sciences, Engineering, Information Systems, Computer Science, Quality discipline or equivalent. Fifteen (15) years relevant work experience with 7 years leadership supervisory role in a global organization. Operational/Quality experience (e.g., GMP, GCP, IT). Experience working across business/operational functions in a regulated environment and at an enterprise level preferred. Experience building sustainable and advanced data integrity, computer systems assurance strategies, advanced analytics, and data governance driving proactive quality management and digital/data insights enabled predictive models.

    Required: In-depth knowledge in the following areas: Strategic leadership across data integrity/governance and Computer Systems Assurance (CSA/CSV) programs and operations, including data quality, master data management, metadata, and governance frameworksAdvanced analytics, business intelligence, risk management, and data-driven decision-making leadershipProven ability to lead digital transformation, organizational change, and process modernization initiatives. Exceptional cross-functional leadership, stakeholder engagement, and influencing skillsStrong governance, risk management, and inspection readiness experienceHighly collaborative and effective at building strong enterprise and cross-functional relationships; a strategic change leader who delivers results through influence, partnership, and leadership.Comfortable in a demanding, fast-paced, patient-focused environment with a start-up culture and evolving processes; flexible and able to adapt as business needs change.Hands-on, action-oriented leader willing to roll up their sleeves, with the flexibility to adapt to a start-up environment. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

    Benefits

    At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

    Pay

    Pay Range: $228,000 - $342,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

    Schedule

    Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site:

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