Title: GxP Systems Lead / PM - Pharma Location: Remote Summary: We are currently seeking a
GxP Systems Lead SME who is experienced, but equally important, very hands-on, execution-focused, and able to work with a strong sense of urgency.
While this is a senior/experienced role, we are not looking for someone who provides primarily advisory or strategic input. We expect this resource to take ownership, actively produce deliverables, drive work forward, and build alignment across stakeholders with minimal oversight.
Key Skills - Expertise in managing a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS) ITSM tools (SNOW)
- Strong expertise in Computer System Validation (CSV)
- Must have GCP (Good Clinical Practice) and R&D expertise
Responsibilities: - Proven hands-on experience supporting a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS), as well as non-Veeva systems/platforms (e.g., Egnyte, DOT Compliance, etc.) in regulated environments.
- Strong expertise in Computer System Validation (CSV), including risk-based validation and end-to-end ownership of validation lifecycle deliverables (URS, FS, IQ/OQ/PQ, TM, etc.) from initiation through closure.
- Strong knowledge of global GxP regulations (FDA, EMA, ICH), GAMP 5, and their practical application to IT systems, with a focus on maintaining audit and inspection readiness.
- Demonstrated project management experience, including planning, execution, risk management, and delivery of system implementations and enhancements.
- bility to effectively collaborate with cross-functional stakeholders across Quality, Clinical, Regulatory, and IT to gather requirements, drive decisions, and deliver compliant solutions.
- Experience managing system configurations, releases, integrations, and enhancements across both Veeva and non-Veeva systems, including change controls and impact assessments.
- Strong understanding of data integrity principles (ALCOA+), system governance, SOP development, and vendor management for GxP applications.
- Experience performing gap assessments against current SOPs and regulatory requirements and executing the subsequent remediation work would be a plus.
Qualifications: - Bachelor's degree (or equivalent work experience) in IT, Engineering, or related science and math discipline with a Technology emphasis.
- Expertise in managing a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS) ITSM tools (SNOW)
- Strong expertise in Computer System Validation (CSV)
- Strong knowledge of global GxP regulations (FDA, EMA, ICH), GAMP 5, and their practical application to IT systems.
- bility to understand complex business needs and adapt appropriately.
- bility to collaborate with senior-level management.
- bility to lead/influence others effectively.
- Strong & Effective communication and presentation skills.
Qualified Candidates Only : If you wish to learn more about this opportunity and additional qualifications/responsibilities, please submit your resume . To learn more about Ekman Associates, Inc. please visit our website at www.ekmanassociates.com
