Associate Director/Director, IT Development Business Partner and GxP Compliance Lead
Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company’s initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts.
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.
Don’t check off every box in the requirements listed above? Please consider applying anyway. We want the best candidates for the job, and those candidates don’t always meet 100% of the qualifications listed. At Verve, we are dedicated to building diverse and inclusive teams who embody the values we share: grit, spirit, drive, and passion. We look forward to learning more about your unique background.
EEO Statement
Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & Staffing Agencies
Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.
Top Skills
What We Do
Verve Therapeutics is a clinical-stage biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve’s gene editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. The company is advancing a pipeline of precision genetic medicines, led by VERVE-101, which is being developed initially for heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease. In 2023, Verve was recognized as a "Best Places to Work" by the Boston Globe. Verve is headquartered in Boston, Massachusetts