GxP Compliance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The IT GxP Compliance Specialist ensures that Software Strategy & Operations (SSO) processes, systems, and documentation implement to GxP regulations and Global Corporate Compliance Guidelines. Key responsibilities include supporting quality management systems, conducting audits, ensuring regulatory compliance, and providing guidance on compliance requirements. The role also focuses on improving quality and velocity across SSO Agile teams, maintaining the Quality Management System, Information Security Management System, SDLC, SOPs, and tool instructions. Additionally, the specialist acts as an internal auditor, creates audit reports, and follows up to resolve audit findings.

Key Responsibilities:

• Maintaining compliance with applicable GxP regulations (FDA, EMA, ICH, WHO, etc.) across all relevant activities.
• Provide subject matter expertise on regulatory requirements for GxP-compliant systems, processes, and documentation.
• Stay up-to-date on global regulatory developments and their impact on the organization.
• Develop, implement, and maintain GxP policies, procedures, and processes.
• Support internal and external audits and regulatory inspections by preparing documentation and coordinating responses to observations.
• Ensure the organization's training programs meet GxP requirements, and maintain training records.
• Conduct risk assessments to identify and mitigate compliance risks.
• Participate in change control processes, ensuring compliance with GxP standards during system updates or process changes.
• Create, review, and approve controlled documents, including SOPs, work instructions, and validation protocols.
• Ensure accurate and timely maintenance of all GxP compliance documentation.
• Maintain and supervise audit trails for GxP-related activities and systems.
• Support validation activities for GxP systems, including equipment, software, and processes (e.g., IQ, OQ, PQ).
• Collaborate with IT and other departments to validate electronic systems in accordance with GxP requirements (e.g., FDA 21 CFR Part 11, EU Annex 11).
• Conduct internal GxP audits to assess compliance with regulations and company standards.
• Prepare for and support external regulatory inspections and third-party audits.
• Track and follow through on audit findings and corrective and preventive actions (CAPAs).
• Partner with cross-functional teams (e.g., R&D, Manufacturing, Clinical Operations) to ensure GxP compliance throughout the product lifecycle.
• Offer mentorship and training to employees regarding GxP regulations and standard methodologies.

Position Qualifications:

• Required
• Bachelor’s degree in Life Sciences, Quality Management, Regulatory Affairs, or a related field.
• 3+ years of experience in a GxP-regulated environment (pharmaceuticals, biotech, medical devices, or similar industries).
• Solid understanding of global GxP regulations and standards (FDA 21 CFR, EMA, ICH guidelines, etc.).
• Experience with QMS tools and electronic document management systems (e.g., Documentum, Veeva, MasterControl, or similar).
• Fluent in English
• Preferred
• Advanced degree or certification (e.g., ISO, RAC, ASQ CQA, RAPS) is a plus.
• Experience with electronic signature tools and systems validation (FDA 21 CFR Part 11 compliance).
• Previous experience in hosting or supporting regulatory inspections.
• Familiarity with project management tools and methodologies.
• Familiarity with Agile methodology (ex. Scrum, Agile, SAFe)
• 2+ years of experience using Atlassian (JIRA and Confluence)

Knowledge, skills:

• In-depth understanding of GxP principles and regulatory frameworks.
• Proficiency in risk management and validation processes.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and attention to detail.
• Ability to work independently and collaborate in a team environment.
• Critical thinking and problem-solving skills.
• Ability to work in a fast-paced environment.The IT Compliance Specialist will be supporting for ensuring that the governance, development, and maintenance of Software Strategy & Operations Software Development Cycle (SDLC) is aligned with ISO 9001:2015, ISO 27001:2013, ISO 27001:2022, GxP and Corporate Guidelines.