Catalent Pharma Solutions Quality Systems Manager in Swindon, United Kingdom
Catalent’s +1,500 strong, international quality team is focused on delivering nearly 7,000 products to patients in over 80 countries with the highest level of quality standards across multiple superior drug delivery and manufacturing technologies at more than 30 facilities.
We are seeking a highly engaged Quality Systems Manager to join our Swindon site. You will be required to manage the Quality Management System (QMS) as it relates to the requirements of the Internal Customer. Knowledge of directives and guidelines such that there is confidence and knowledge that the Quality Management System is fit for purpose, adapts to the needs of the business and is compliant.
Provide training coaching and support to QMS personnel.
Develop and maintain the QMS for compliance with current and evolving regulatory requirements to ensure the QMS remains compliant.
Ensure the processes needed for the QMS are established, implemented and maintained.
Provide metrics on the performance of the QMS and to identify and implement changes required based on that data.
Understand the internal customer requirements and ensure these are supported by the QMS, whilst maintaining compliance.
Make proposals and drive initiatives to improve efficiency or overall quality of the department.
To maintain the Supplier Assurance system
Ensure all activities within the team are conducted in accordance with relevant regulatory guidelines, cGMPs, protocols and SOPs thus ensuring the requirements of customers and regulatory bodies are met.
Build an extensive network of contacts and use them effectively as required in order to complete quality tasks.
Represent QMS as a customer contact (via email, phone, teleconferences, face to face) demonstrating internal and external customer focus, negotiation skills and flexibility.
Demonstrated management/supervisory experience.
Must have not less than 5 years experience in a quality environment, for pharmaceutical or medical devices.
Appropriate Science based Degree or relevant industrial experience.
An IRCA lead auditor qualification would be an advantage
Why Work for Us:
Our Vision is to be the world’s most trusted, reliable and innovative drug development and delivery
partner by upholding the highest industry standards and exceeding customer expectations, while driving
strong, sustained growth for the company.
Competitive salary package + Bonus + Contributory Pension
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally.
Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.
OUR VALUES are at the foundation of everything we do:
Patient First: We put patients at the centre of our work to ensure the safety, reliable supply and optimal performance of our products.
Customer Dedication: We strive to exceed our customers’ expectations every day.
People: We are committed to the growth, development and engagement of our people.
Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes.
Integrity: We demonstrate respect, accountability and honesty in every interaction.
Excellence: We have a passion for excellence in everything we do.
Catalent. More products. Better treatments. Reliably supplied.™ Visit www.catalent.com/careers to explore career opportunities.
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.