Director, Quality – Digital Systems Compliance

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.

Reporting directly to the Vice President, Quality, the Director, Quality – Digital Systems Compliance is responsible for ensuring that all automated systems supporting cGMP processes align with applicable regulations throughout their software life cycle, including development, implementation, and maintenance. This role ensures Quality oversight and alignment with the Division’s global quality system, partnering with IT, Operations and Quality teams to establish robust validation, electronic infrastructure, and data integrity, including IT compliance and Computer Information Security.

Responsibilities

• Lead and mentor a team of Quality professionals committed to computer systems compliance and validation of critical business systems.
• Coordinate all aspects of the company's Computer System Validation (CSV) and global IT activities supporting cGMP processes within the division.
• Collaborate with Operations, IT, Finance, and QA personnel to develop, implement, manage, release, periodically review, and maintain new and updated IT systems.
• Integrate Risk Management tools into a compliant Computer System and Automation Validation approach.
• Plan, prioritize, and direct QA Automation Validation and IT compliance functions.
• Develop and communicate a clear vision, propose plans, and lead project results to support the growing CSV needs of the business, improving and optimizing the program.
• Establish effective communication and collaborative relationships with all business units, global sites, and key partners.
• Develop, revise, and implement QA IT and CSV policies and procedures to ensure global harmonization and alignment across global operating sites.
• Provide subject matter expertise during regulatory and customer inspections of Clinical Trials Division business sites.
• Proactively establish, communicate, and lead QA and Validation strategies, needs, requirements, and associated plans for existing and new computer systems.
• Support and collaborate with global QA organizations to ensure ongoing validation of computer systems throughout their life cycle.
• Maintain current knowledge of industry standards and regulatory requirements.
• Proactively identify, and own the resolution of critical, high-risk compliance deficiencies through effective resolution management within the current quality system for deviations, risk management, and change control.

Requirements

• Education: Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field preferred.
• Experience:
  • Proven experience in Quality Assurance, Quality Control, or Compliance roles within the pharmaceutical, biotechnology, or medical device industries required.
  • Demonstrated experience specifically in CSV and IT compliance.
  • Proven track record of leading and developing teams in a regulated environment.
  • Strong understanding of cGMP processes and requirements.
• Skills:
  • Excellent project management skills with the ability to manage multiple priorities.
  • Strong communication and teamwork skills to work effectively with cross-functional teams.

Company Information

Thermo Fisher Scientific Inc. is dedicated to encouraging a diverse and inclusive environment where all employees are valued and respected. As an equal opportunity employer, we encourage applications from all qualified candidates. Join us and be part of a team that champions excellence and innovation in everything we do.