Quality Manager Croydon, England
Job description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Are You ready to make an impact?
#Thisiswhere you discover our new opportunity for a Quality Manager to join our Croydon Compounding Facility.
At Baxter, our managers influence our teams and use a dedicated approach in alignment with our culture levers using Speed, Simplicity, Teamwork and Courage. They build trust, champion inclusion, and support our mission in a fast-paced and agile work environment.
This is a key role in ensuring patient safety and product quality whilst supporting continuous improvement and the strategic growth of Baxter Compounding through partnering with the NHS and private healthcare providers.
If you are looking for a place where you get to work with hard-working and dynamic people whose primary focus is to save and sustain lives and whose work values focus on speed, simplicity, courage and collaboration. Then we would love to hear from you.
Some of the responsibilities include:
- Develop and implement the site Quality Plan to achieve Quality Objectives
- Lead and own the Quality Assurance team within the compounding unit.
- Mentor, coach and share subject matter expertise to support the development and capabilities of the team.
- Ensures appropriate risk identification and management processes are implemented in the compounding unit.
- Responsible for implementation and management of the Baxter Pharmaceutical Quality System within the compounding unit.
- Ensures that the unit is aligned with the Manufacturing license, MHRA and EU GMP requirements (and customer requirements.
- Be named as Quality Controller on the Manufacturing (MS) License
- Accountable for the management of product release processes, ensuring the product meets specification and customer order/ prescription and is released according to schedule.
- Partners with Manufacturing, Engineering and Validation functions to ensure the unit meets customer expectations regarding product quality and supply.
- Responsible for monitoring, measurement and analysis of metrics and KPIs to confirm the efficient process of the Quality Management System through the Quality Management Review process.
Education and/or experience
- Degree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology / Engineering
- Experience working within a leadership position
- Proven knowledge of Quality Management System processes
- Understanding of current EU and UK GMP requirements or experience of working within ISO 9001, ISO 13485, MDD 93/42/EEC, or similar regulations and standards
- Must have direct experience in Aseptic Manufacturing of Sterile Medicines or Compounding
- Lean Six Sigma certified (desired)
- Lead Auditor (preferred)
We offer you:
- Competitive total compensation package
- Professional development opportunities
- High importance is placed on work-life balance
- Dedication to growing and developing an inclusive and diverse workforce
#ind-ukops
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
