Business Quality & Vendor Oversight Compliance Manager
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Posted on:
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Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 youll 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 worlds 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 youll play a crucial role in ensuring regulatory excellence and document control across Evidera operations. Working closely with business unit partners youll support the centralized Business Quality and Vendor Oversight team across the Evidera business unit. Youll 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 Bachelors 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
Manager
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
