Director, IT GxP and Lab Services

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description: 

The Director of IT GxP and Lab Services is a leadership position responsible for the strategic oversight, management and execution of GxP-compliant IT platforms and systems, lab IT infrastructure and related services within Wave. This role plays a critical part in ensuring that all IT systems supporting regulated environments (GxP) and laboratory operations adhere to regulatory standards such as FDA, EMA and other global regulatory bodies. The Director will lead a team of IT professionals and work cross-functionally with Research & Development (R&D), Quality Assurance, Regulatory Affairs, Manufacturing, Facilities & Engineering, and external vendor/partners to maintain and improve IT systems that support Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).

Education & Experience:

• Batchelor’s degree in Information Technology, Computer Science, Engineering or a related field is required. Advanced degree is preferred 
• At least 10-12 years of experience in IT, with at least 5 years in leadership role supporting GxP-regulated environment (GMP, GCP, GLP) and lab services in life sciences industry
• Strong experience with regulatory environment and knowledge of FDA, EMA, MHRA and other regulatory requirements
• Hands-on experience managing IT projects involving GxP compliance. Computer systems validation (CSV) and 21 CFR Part 11 requirements.
• Strong experience with Veeva platform roadmap and roll-out, including leveraging Veeva Quality, Clinical and Regulatory vaults and workflows   
• Experience with lab systems such as LIMS, Scientific Data Management Systems (SDMS) and other lab automation systems
• Experience with vendor management including vendor audits and qualifications

Responsibilities:

• Lead and manage the IT GxP and Lab Services team, providing direction, mentorship, and support to ensure the successful execution of projects and initiatives
• Develop and execute the strategic roadmap for IT systems in GxP-regulated environments and lab services, align with corporate objectives and compliance requirements
• Lead planning, implementation and management of IT solutions to support GMP, GLP and GCP environments, ensuring seamless integration with lab workflows and business processes
• Champion adoption and continuous improvement of Wave GxP platforms and lab systems, lead automation and digital transformation initiatives in the lab and regulated spaces, driving innovation and efficiency
• Ensure IT solutions are scalable, cost-effective and align with future organizational growth and industry trends
• Ensure that all IT systems and processes comply with regulatory requirements (FDA, EMA, MHRA etc.) and industry best practices related to GxP
• Lead audits, both internal and external related to IT systems and infrastructure supporting GxP operations
• Develop and maintain IT validation strategies and oversee system validation activities for GxP systems, including computer system validation (CSV) and electronic signatures (21 CFR Part 11)
• Oversee the implementation, maintenance, and optimization of laboratory informatics systems, including Laboratory Information Management System (LIMS) and lab automation technologies
• Drive collaboration w/ lab managers and scientists and R&D staff, and IT services with evolving lab needs
• Provide strategic oversight of Veeva platform, drive best practices and effective integration with enterprise and lab platforms
• Lead and manage a team of IT professionals responsible for GxP compliance and lab IT services
• Provide coaching, mentorship and development opportunities to enhance team performance and skill sets
• Manage partnerships and relationships with external vendors and services providers, ensuring service level are met and external solutions meet Wave GxP and lab requirements.

Key Skills: 

• Deep understanding of GxP regulations, including FDA, EMA and other regulatory standards and experience with 21 CFR Part 11 and GAMP5 standards
• Technical proficiency in GxP IT systems, lab informatics and enterprise platforms and hands-on experience in Veeva configurations
• Proven ability to lead and manage large-scale IT projects, particularly in regulated environment
• Strong leadership and team building skills, with ability to manage and mentor a diverse group of IT professionals
• Excellent organizational, time management collaboration and analytic skills
• Strong communication and written skills, with the ability to articulate complex technical concepts to non-technical audience
• Understanding of data privacy regulations, GDPR, HIPPA and application in IT system and life science industry

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.