Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Position Summery: We are looking for a dedicated, resourceful Quality minded individual with up-to-date knowledge, and passion for driving and sustaining improvements to the QMS to ensure compliance to all relevant cGMP regulations. Every day could be different leading and supporting a range of activities including risk management, internal & external audits, training, change control, deviations and CAPA, supplier assurance, document lifecycle, and metrics reporting. As process owner for one or more of these processes we want someone to drive the ownership and accountability for process compliance. This will require staying up to date with standard processes, corporate and regulatory requirements. A day in the life: By leading internal audits, you will support site inspection readiness whilst collaborating sitewide to ensure key objectives are efficiently achieved. As a qualified trainer, sharing knowledge, through structured training & using innovative technologies will excite you! Writing, reviewing and approving a wide-range of documents, including procedures, deviations, CAPA etc. Efficient use all of the available electronic tools (e.g. Trackwise, eDMS, SFLMS), to support site success in a variety of tasks associated with Quality systems and compliance responsibilities. Utilising innovative tools you will be at ease extracting, analysing, and interpreting QMS data to support management reporting, proposing solutions to any trends identified and collaborating on resolutions. A proactive approach to problem solving, challenging assignments & working to critical timelines is important to facilitate quality compliance As a credible leader you will provide inspiration, mentorship, and support to the team. You will deputise for the Quality Compliance Manager when required ensuring continuity and effective management of compliance duties. In order to support the organisation you will step up for other quality related tasks where required. Embodying the companies 4i values of integrity, intensity, innovation, and involvement. Strong motivation for improving and streamlining processes, and active participation in the continuous improvement program (PPI). As an advocate for EHS you will ensure compliance with environment, health and safety rules, timely reporting of any accidents & near misses. This is a diverse role, with the opportunity for exposure to different quality functions. As a self-motivated and passionate candidate, there really is no limit to the growth and experience on offer and as a global leader, we can offer you all sorts of opportunities! Education & Skills Relevant science based degree; e.g. Chemistry, Biology, Pharmacy or equivalent 5 years relevant pharmaceutical/ biotech experience in a regulated environment (e/g FDA, EU GMP, JP) Demonstratable understanding of the principles and guidelines for cGMP Qualified Lead auditor Able to communicate well to all levels of the business Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.