As the world leader in serving science, Thermo Fisher Scientific is dedicated to solving the world’s toughest problems. From giving cancer patients hope to ensuring water and food safety, and even aiding law enforcement through forensics, our work touches lives every day. Most recently, we’ve been at the forefront of providing COVID-19 solutions.

Our Data Science, Digital, and IT careers offer a unique opportunity to apply your specialized skills in analytics, statistics, data science, programming, and information technology to drive our mission of making the world healthier, cleaner, and safer. When you join us, you’ll make an impact both inside and outside the company on work that truly matters.

Job Description: IT GxP Compliance Specialist

As an IT GxP Compliance Specialist, you will play a critical role in ensuring that our Software Strategy & Operations (SSO) processes, systems, and documentation comply with GxP regulations and Global Corporate Compliance Guidelines. This role is essential in maintaining the integrity of our quality management systems, conducting audits, and ensuring regulatory compliance across all relevant activities.

Key Responsibilities:

1. Regulatory Compliance:
   • Maintain compliance with 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 updated on global regulatory developments and their impact on the organization.
2. Quality Management:
   • 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.
3. Risk Management:
   • 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.
4. Documentation & Validation:
   • Create, review, and approve controlled documents, including SOPs, work instructions, and validation protocols.
   • 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).
5. Audits & Inspections:
   • 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).
6. Collaboration & Training:
   • 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 best practices.

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).
• 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 (e.g., Scrum, Agile, SAFe).
• 2+ years of experience using Atlassian tools (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 thrive in a fast-paced environment.

Why Join Thermo Fisher Scientific?

• Impactful Work: Contribute to solving global challenges in healthcare, environmental safety, and more.
• Career Growth: Opportunities to grow within a global leader in science and technology.
• Hybrid Work Model: Enjoy the flexibility of a hybrid work environment.
• Training & Development: Access to continuous learning and professional development programs.

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