Business Quality & Vendor Oversight Compliance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Compliance Manager - Business Quality & Vendor Oversight. Make an Impact at the Forefront of Innovation. As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges.

DESCRIPTION:

Join our Operational Strategy and Business Innovation team in a dynamic role that combines controlled document oversight, quality assurance, vendor and application oversight and innovative technology solutions. As Compliance Manager, you'll play a crucial role in ensuring regulatory excellence and document control across Evidera operations. Working closely with business unit partners, you'll support the centralized Business Quality and Vendor Oversight team across the Evidera business unit. You'll lead the management of controlled documents, drive compliance initiatives, and guide AI-driven solutions by developing guardrails to enhance efficiency and ensure compliance. This position offers the opportunity to make a significant impact by managing risk, fostering relationships with internal and external stakeholders, and driving continuous improvement in compliance and document control processes.

What you will do:

• Controlled Document & Quality Governance

  • Lead oversight of business unit controlled documents within the Quality Management System to ensure alignment with Thermo Fisher Scientific quality requirements

  • Serve as Controlled Document Liaison (CDL), track periodic reviews, coordinate SME contributions, author select documents, conduct technical review and lead change control activities

  • Identify and implement process improvements to strengthen document control

• AI Governance & Technology Innovation

  • Lead development and implementation of Evidera AI policy and guiding principles, maintain policies and assess needs going forward.

  • Implement AI technology-enabled solutions to improve document management and compliance efficiency

• Vendor & Computer System Oversight

  • Manage vendor oversight activities, including onboarding, qualification, audits, performance monitoring, vendor quality events and KPI tracking

  • Oversee strategic computer system applications, supporting onboarding, oversight, audits and compliance

  • Partner with Vendor Management and Information Technology and business stakeholders

• Audit, Compliance & Continuous Improvement

  • Lead and support internal, client, and regulatory audits

  • Review and approve audit reports and remediation plans

  • Identify and resolve quality and compliance risks impacting clinical research programs

  • Provide reporting, escalation management, and compliance visibility to leadership

  • Drive Practical Process Improvement (PPI) initiatives to enhance efficiency and reduce operational burden

REQUIREMENTS:

How you will get here:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in compliance management, document control, or related field in a multinational company

• Preferred Fields of Study: Life Sciences, Quality Management, Information Technology, Business Administration, or related field

• Advanced degree, relevant certifications, or specialized compliance credentials preferred

Qualifications:

• Extensive knowledge of GxP regulations, document control processes, and quality management systems

• Expert knowledge of SOPs and WPDs, including experience managing controlled documents in a Quality Document Management system

• Strong understanding of vendor management processes and oversight requirements

• Advanced knowledge of computer system validation and compliance requirements

• Experience managing technology vendors (applications), acting as business owner and tracking performance

• Demonstrated ability to lead AI policy development and implement technology solutions in a regulated environment

• Experience using and/or developing AI technologies to drive innovation and efficiency in clinical trial research

• Experience with AI strategy and application in research, ensuring compliance with GCP and regulatory standards

• Experience in conducting audits, managing CAPAs, and implementing corrective actions

• Expertise in quality management systems and regulatory frameworks (GMP, GCP, etc.)

• Proven track record in project management and cross- functional team leadership

Knowledge, Skills, and Abilities:

• Strong analytical skills with the ability to interpret and apply complex regulations

• Excellent organizational and time management skills to handle multiple priorities

• Advanced proficiency in Microsoft Office Suite, Veeva Quality Docs, and other relevant software

• Exceptional communication and presentation skills

• Demonstrated ability to influence and collaborate across organizational levels

• Strong problem- solving skills and attention to detail

• Proficiency in data analysis and performance metrics tracking

• Ability to adapt to changing regulatory landscapes and emerging technologies

• Strategic thinking with a focus on process improvement and efficiency

Travel Requirements:

• May require occasional travel for audits, vendor site visits, or cross-site collaboration (up to 10%)

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.