Director, GxP Training & Learning Strategy (Hybrid)

Vertex Inc. • Boston, MA

5d • Hybrid

About The Position

We are seeking a Director to define and lead the enterprise GxP training strategy. This role sits at the intersection of business strategy, Quality governance, and operational enablement. The Director partners with senior leaders to understand business direction, clarify why training solutions are required, and translate regulatory and operational needs into a clear, prioritized roadmap with defined outcomes and accountability. In parallel, as QSO, the Director holds final authority for the system-level design, governance, compliance, and continuous improvement of the GxP Training Quality System within the Global QMS framework. The Director ensures the system remains compliant, effective, scalable, and inspection-ready across Small Molecule, Cell & Gene Therapy, Biologics, and Device operations. The Director also serves as Business System Owner for the LMS and leads a team of Strategic Training Partners aligned to operational and functional business areas. This is a strategic and governance leadership role requiring business acumen, regulatory judgment, and decision authority.

Requirements

• Bachelor’s degree required; advanced degree preferred.
• 10+ years of experience in GxP training, quality systems, within regulated operational environments (or demonstrated equivalent) within pharma or biotech. This is highly preferred.
• 5+ years in a leadership role with accountability for strategy, governance, and people leadership.
• Demonstrated experience operating within a formal Quality System governance framework with deep expertise in fundamental quality disciplines and requirements (e.g., quality risk management, change management, corrective and preventing action, and inspection readiness).
• Strong working knowledge of FDA, EMA, and ICH GxP expectations.
• Proven ability to translate business and regulatory requirements into actionable strategies and defensible system-level decisions.
• Experience using performance data and quality metrics to inform governance and executive decision-making.
• Demonstrated ability to exercise sound judgment and lead through complexity.

Responsibilities

• Define and evolve the enterprise GxP training strategy in alignment with business objectives, growth plans, and regulatory expectations.
• Provide leadership in Global Process Ownership and Compliance (GPOC) by driving proactive quality approaches across the GxP process lifecycle, fostering a culture of continuous improvement, and ensuring that training programs are designed to enhance compliance, mitigate risks, and support operational excellence.
• As Quality System Owner for the GxP Training Quality System, the Director will steward the system end-to-end within the Global QMS Governance framework.
• Use system-level KPIs, inspection insights, and quality performance data to assess Training Quality System health, drive continuous improvement, and escalate risks when impact exceeds defined thresholds.
• Represent the Training Quality System credibly and consistently during audits, regulatory inspections, and executive governance reviews.
• Ensure that technology architecture, configuration, and operating practices support both regulatory integrity and business effectiveness.
• Lead and develop a team of Strategic Training Partners, ensuring they operate as credible, business-aligned advisors.

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director