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.

Summary

We are seeking an outstanding and hardworking Quality Manager to join our Oxford Compounding Unit. Working closely with the local Unit Manager, Engineering, Validation teams and wider Baxter network you will report directly to the Head of Quality forming an integral part of the Senior Quality Leadership team.

We are looking for a highly motivated and capable individual with previous Pharmaceutical Quality experience who can demonstrate the leadership and technical qualities required for this role. You will have an inclusive, agile, solutions focused approach with an ability to demonstrate our Baxter cultural levers of Speed, Simplicity, Collaboration and Courage.

The rewards for the individual include competitive salary and benefits, continuous development opportunities and a long-term career in an interesting and stimulating 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 NHS and private healthcare providers.

Essential Duties and Responsibilities

• Develop and implement the site Quality Plan to achieve Quality Objectives
• Lead and manage 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 compliant with the Manufacturing license, MHRA and EU GMP requirements (with particular reference to the manufacture and supply of ‘Specials’), customer requirements.
• Be named as Quality Controller on the Manufacturing (MS) License
• Be responsible for management of product release processes, ensuring product meets specification and customer order/ prescription and is released according to schedule.
• Ensure that unit is compliant with all Baxter corporate Quality Management System policies, procedures and standards through execution of internal audit program.
• Works closely 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 effective implementation of the Quality Management System through Quality Management Review process.
• Responsible for timely effective corrective & preventive actions which eliminate risk to product quality, safety and efficacy and drive continuous improvement.
• Ensure Regulatory, Corporate and Customer audits are managed successfully.

Education and Experience

• Degree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology / Engineering
• Experience working within a leadership position
• Proven knowledge of Quality Management System processes (essential), with working knowledge of current EU and UK GMP requirements (EU GMP Annex 1) (preferred), or experience of working within ISO 9001, ISO 13485, MDD 93/42/EEC, or similar regulations and standards (considered).
• Must have direct experience of Aseptic Manufacturing of Sterile Medicines or Compounding
• Lean Six Sigma certified (desired)
• Lead Auditor (preferred)

Experience in any of the following:

• Investigation and CAPA Management
• Internal and Supplier audits
• Hosting External (i.e. MoH / MHRA) audits
• Environmental/Microbiological/Contamination control
• Validation
• Risk Management
• Project Management

Demonstrate:

• Critical thinking and decision making
• Personal accountability and sense of urgency
• Ability to work and multi task under pressure with others in a fast paced manufacturing environment
• Effectively manage upwards and communicate with Senior Leadership
• Excellent verbal and written communication skills
• Collaboration and teamwork
• Navigating through ambiguity
• Good management and communication skills
• Customer and patient focus

What are some of the benefits of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce

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.

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