📍 Location: Fully Remote
🌎 Global collaboration across US, Europe and APAC

About the Role:

We are looking for an experienced Systems Manager – GxP Compliance Systems to oversee the governance, validation, and continuous improvement of regulated systems that support GxP-compliant operations across the organization.

You will work closely with Quality, IT, Regulatory Affairs, Manufacturing, and Clinical teams to ensure the compliant operation of critical systems across the organization.

Key Responsibilities

• Manage and maintain GxP-regulated systems supporting quality, clinical, regulatory, and manufacturing operations.

• Ensure compliance with FDA, EMA, MHRA and global regulatory requirements.

• Lead Computerized System Validation (CSV) activities including validation planning, risk assessments, IQ/OQ/PQ protocols, and periodic reviews.

• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity standards (ALCOA+).

• Serve as System Owner or Business System Manager for designated platforms.

• Support internal audits and regulatory inspections, ensuring systems remain audit-ready.

• Collaborate with IT teams and external vendors to maintain system performance and compliance.

• Identify opportunities to optimize systems, improve processes, and support digital transformation initiatives.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or related field

• 7+ years of experience in the pharmaceutical, biotechnology, or life sciences industry

• 5+ years managing GxP-regulated systems

• Experience with Computerized System Validation (CSV)

Experience with systems such as:

• QMS

• Document Management Systems (Veeva, MasterControl)

• LIMS

• CTMS / eTMF

• MES

• RIMS

Strong knowledge of:

• 21 CFR Part 11

• EU Annex 11

• GAMP 5

• ICH guidelines

• Data integrity principles

Preferred

• Experience with cloud-based validated systems

• Experience supporting global regulatory inspections

• Certifications such as GAMP, ITIL, or PMP

💡 Why join us?

• Fully remote role

• Work with global cross-functional teams

• Opportunity to lead critical compliance systems in a highly regulated environment

• Contribute to digital transformation initiatives in life sciences