Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position Summary & Key Responsibilities:
Reporting directly to the Quality Systems Manager, the jobholder is responsible for providing effective leadership for all aspects of the Quality Systems Support (QSS) team, providing quality assurance for the execution and documentation of activities critical to the ongoing health of the FCS Horsham site’s Quality Management System (QMS) and maintaining site compliance with GxP requirements.
QSS team management
- Lead and oversee all activities performed by the QSS team, ensuring timely, compliant execution of electronic QMS processes.
- Act as Site Subject Matter Expert (SME) for QSS-owned processes, supporting client audits and regulatory inspections as required.
- Deputise for the Quality Systems Manager when required.
QMS Oversight & Compliance
- Review and approve investigations, CAPAs, change controls, action items, and effectiveness checks.
- Ensure assigned QMS actions are completed accurately and on time.
- Author, review, and approve Quality documentation in line with site and global requirements.
- Support additional QMS activities, such as site audits, risk assessments, gap analyses, and document lifecycle activities.
Team Leadership & Development
- Provide clear leadership, coaching, and direction to the QSS team.
- Drive individual and team development through structured goal planning and performance enablement.
- Foster a strong Quality culture through proactive engagement, learning, and information sharing.
Continuous Improvement & Metrics
- Develop and execute continuous improvement initiatives aligned with PPI, including identification of cost-saving opportunities.
- Deliver meaningful Quality Systems metrics and data to support site and global performance reviews.
- Participate in site management review activities and cross-functional improvement projects.
Global Collaboration
- Contribute to global Quality initiatives to drive harmonisation and improvement of QMS processes.
- Support global system development and implementation activities.
Experience, Knowledge & Skills:
- Significant experience in GxP Quality role/s with an understanding of regulatory requirements, particularly with respect to deviation, CAPA and change management.
- High level of working knowledge of TrackWise or similar electronic QMS.
- Proven ability to lead a team, including an understanding of how to motivate, develop and manage staff.
- Strong written and verbal communication skills, capable of influencing and collaborating across all functions and levels, with both internal and external customers, to achieve business objectives.
- Adept at balancing competing priorities and making GxP risk-based decisions under pressure.
- Proficient using Microsoft Office packages
How will you get here?
- Demonstrate behaviours in line with the Thermo Fisher Core Competencies and 4i Values.
- Demonstrate an ownership mindset, maintaining accountability for all team responsibilities.
- Demonstrate an adaptive and flexible working style, capable of managing a strategy which respects both Quality risk and business need.
- Promote and ensure compliance with cGMP, Quality Systems and training requirements.
- Hybrid role
About Thermo Fisher:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.