Senior Quality Specialist

Danaher Corporation ,
Cardiff, South Glamorgan
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Job Description

Help us improve access to life-changing therapies that can transform human health We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020. Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes. We are looking for a Senior Quality Specialist to lead the execution of the total quality strategy for the G&CR manufacturing sites (Tonglu, Dassel and Cardiff) focusing on both compliance and product quality. They will be responsible for driving total quality metrics for the business, including the Balanced Scorecard and QMS compliance. Do you have a passion for Quality Assurance? Then we would love to hear from you. What you'll do + Ensure product quality is visible and actionable. Escalate issues, risks and deficiencies through quality, functional and operating teams where required to achieve adequate focus and attention. + Prioritize Quality actions and uses a risk-based approach - Partners with Manufacturing, Engineering, Supplier Management and Service to determine ownership, priority, and resolution. + Coordinates with other sites in the same modality to ensure product issues and priorities, quality metrics are aligned, well-understood and addressed. + Coordinates regulatory activities across the G&CR sites. Ensure audit readiness is maintained and audit support is superbly executed. + Implement and adhere to the all applicable regulations at the site and ensure others sites do the same through education and training. + Ensure day to day compliance - QMS, policy, regulatory. Stay abreast of industry Quality and Regulatory trends and developments. + Participates in NPI reviews. + Support and aid in modality adoption of operational excellence improvements Who you are + Bachelor's Degree in medicine, pharmacy, engineering or other relevant scientific discipline and a minimum of 3 year professional experience in regulatory affairs or quality management systems relating to medical devices or a minimum of 5 years of professional experience in regulatory affairs or in quality management systems relating to medical devices or pharmaceutical products. + A minimum of 7 years of professional experience in one or more of the following: quality and regulatory assurance, product development, manufacturing, or quality control in a pharmaceutical or medical device environment. + Very strong professional experience in one or more of the following: quality and regulatory assurance, product development, manufacturing, or quality control in a medical device environment. Desired Characteristics + Strong people leader - instill empowerment and trust within the organization + Change agent - drive & accelerate a Total Quality product culture + Influential leader - ability to work cross-functionally and drive wins for the business; collaborator + Strategic thinker - ability to stay out of the weeds and focus on the future state + Constructive conflict - not afraid to lean into tough conversations to get to the best outcome for the business + Demonstrated knowledge of the Quality Management System (ISO9001/ISO13485) + Able to react with appropriate urgency and professionalism; make decisions under pressure + Strong business acumen - uses financial analysis to make important business decisions understands key financial metrics, can articulate the company's business vision key business objectives, understands business trends and cycles. + Ability to handle competing priorities effectively + Master's degree in Business or other related area + Black Belt or Master Black Belt Who we are Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you'll feel right at home here. If you're flexible, curious and relentless, you'll belong. If you are excited about a global culture, this can be the place to further your career. Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page! Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients. Cytiva is part of the Danaher family of companies, a global science and technology innovator committed

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