ComplianceQuest · 1 day ago
EBR Practice Leader
United States
Full-time
Hybrid
Director/Executive
10+ years expComplianceQuest is a rapidly growing company transforming compliance and quality for the modern enterprise. They are seeking an Electronic Batch Record (EBR) Software Implementation Practice Leader to lead strategy, execution, and delivery of EBR implementation projects across pharmaceutical and life sciences manufacturing environments.
ComplianceSoftware
Responsibilities
Define and drive the vision for EBR implementation services within the organization
Develop methodologies, frameworks, and best practices for successful EBR deployments
Lead end-to-end EBR implementation projects, including requirements gathering, system design, configuration, testing, and go-live
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and other relevant regulatory guidelines
Act as a trusted advisor to clients on digital manufacturing strategies and EBR adoption
Conduct workshops, training sessions, and stakeholder alignment meetings
Build and mentor a high-performing team of consultants and technical specialists
Foster a culture of continuous learning and innovation within the practice
Oversee validation activities (IQ/OQ/PQ) and ensure documentation meets regulatory standards
Implement robust change management and risk mitigation strategies
Support pre-sales activities, including proposal development and client presentations
Identify opportunities for expanding EBR-related services and solutions
Qualification
Required
Bachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or related field
10+ years of experience in pharmaceutical / Biotech/ medical devices manufacturing IT systems, with at least 5 years in EBR implementation leadership roles
Strong knowledge of MES platforms (e.g., MasterControl MX, Tuliop, Werum PAS-X, Emerson Syncade, Siemens Opcenter)
Expertise in GMP, GAMP 5, and regulatory compliance frameworks
Proven track record of delivering complex, multi-site EBR projects
Excellent communication, stakeholder management, and leadership skills
Ability to travel up to 50% of the time
Proximity to Life Science hubs
Ideal candidate should reside in or be near: Philadelphia, Boston, New York / New Jersey, Chicago…or within reasonable proximity to a major U.S. airport hub to support frequent travel
Preferred
Experience with cloud-based EBR solutions and integration with ERP/LIMS systems
Familiarity with emerging technologies such as IoT, AI, and advanced analytics in manufacturing
PMP or equivalent project management certification
Company
ComplianceQuest
The only solution to intelligently automate compliance operations with a unified PLM, QMS, EHS, and SRM.
501-1000 employees
H1B Sponsorship
ComplianceQuest has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$36MKey Investors
Insight Partners
2019-09-10Series A· $36M
Leadership Team
Prashanth Rajendran
CEO
Atulya Risal
CTO, EVP Software Engineering
Recent News
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