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Quality Manager

Req #: JR - 073347 Location Oxford, England, United Kingdom Job Category: Quality Control Date Posted: 06/24/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Quality Manager

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.

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.

073347

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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