Demo

Associate Director/Director, IT Development Business Partner and GxP Compliance Lead

Verve Therapeutics
Boston, MA Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/21/2025

The Position

Verve is seeking an experienced and dynamic Associate Director or Director, IT Development Business Partner and GxP Compliance Lead to work closely with the development groups and lead and enhance our GxP compliance programs in a highly regulated environment. This role will serve as a strategic liaison between business functions and IT, leveraging technology to support key development activities and ensure compliance with industry standards. The ideal candidate will ensure regulatory adherence and align IT operations with business objectives while fostering collaboration across teams and stakeholders, supporting Verve's commitment to quality and accountability.

Job Responsibilities

  • Serve as the primary IT liaison for Quality, Regulatory, Clinical, and other development teams, building strong relationships with stakeholders to understand their strategic goals, operational needs, and opportunities for improvement. Leverage diverse perspectives to tackle complex challenges and develop innovative, actionable strategies aligned with team and company objectives.
  • Lead IT GxP compliance initiatives as a subject matter expert, driving accountability across teams. Oversee the creation of SOPs, documentation, and training programs that meet GxP standards (e.g., 21 CFR Part 11). Ensure audit and inspection readiness by maintaining accurate systems documentation, upholding data integrity, and partnering with auditors to implement, communicate, and remediate processes effectively.
  • Drive the planning, execution, and validation of key projects by aligning priorities, requirements, and timelines with company goals. Allocate resources strategically to maximize efficiency, make confident decisions to keep projects on track, and provide recommendations to shape timelines, goals, and resource allocation for success.
  • Oversee the selection, implementation, and validation of development systems, ensuring compliance with relevant standards. Provide ongoing technical support, troubleshoot issues, and serve as a resource for technical and process-related inquiries.
  • Set clear objectives, delegate responsibilities, and inspire your team to execute plans with focus and alignment to company priorities. Mentor team members, fostering collaboration, resolving roadblocks, and maintaining peak performance. Cultivate an inclusive and collaborative culture that empowers the team to achieve shared goals and models company values.
  • Build strong connections with senior management, colleagues, and external stakeholders, influencing key outcomes and providing insights that shape critical decisions and drive organizational success in high-impact situations.
  • Other duties as assigned.

Qualifications

  • Education & Experience
  • Bachelor’s degree in information technology, computer science, or relevant field.

  • At least 9 years of relevant experience in development business partner or related roles, preferably in a GxP regulated biotech or pharmaceutical environment.
  • Strong understanding of regulatory frameworks relevant to a clinical stage biotech organization.
  • Skills & Abilities
  • Proven ability to lead and develop teams, managing complex projects and solving abstract problems.

  • Strong communication and negotiation skills, with experience influencing stakeholders and aligning organizational objectives.
  • Demonstrated ability to set strategic direction and translate it into actionable plans.
  • High emotional intelligence, with skills in conflict resolution and understanding diverse perspectives.
  • Experience in budget management and accountability for departmental or cross-functional finances.
  • Ability to bring structure to ambiguous situations and develop overarching frameworks for projects.
  • Track record of mentoring and developing future leaders within an organization.
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