Quality Manager (Validation)

Job content

Business Job Title:Quality Manager (Validation)
Internal Job Title:Proactive Quality Manager
Direct Report To:Site Quality Director
Working Hours:Normal working hours are 37.5 hours per week, 0830hrs to 1640hrs, Monday to Friday.

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

At our site in Swindon, Thermo Fisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs.

The role:
We are searching for a highly motivated, proficient and experienced Quality Manager to join our team! You’ll be part of a smart, driven team that shares your passion for exploration and discovery.

In this role, the successful applicant will be responsible to ensure the overall quality of a manufacturing product and will focus on continuous improvement processes. They will proactively lead activities related to quality such as Risk Assessments, data integrity and computer system, process and cleaning validation, Statistical Process Control (SPC), process standardisation and verification to ensure repeatability and consistency.

What you’ll do:

• Lead qualification and validation activities including PPQ, CSV & CPV including risk and CAPA management. In addition, provide mentorship on projects involving GxP relevant computer systems in conjunction with Functional Leads, Systems Administrators, Process and/or Systems Owners incorporating appropriate elements of quality and compliance
  
  

• Ensure the efficient operation of the function and being the subject matter expert of the Validation/Qualification function within a regulated environment
  
  

• Manage and lead risk assessments and mitigation activities to improve Quality Management Systems including process improvement
  
  

• Drive the development of prioritised evaluation, planning and implementation approach for products/projects and work with Program Management to prepare comprehensive project plans with technical quality objectives including risk management
  
  

• Facilitate the assessment of legacy/in-place computer system software applications to ensure their validation documentation packages meet compliance standards, identify gaps and risk exposures
  
  

• Partner with the Corporate Computer Systems Validation/Compliance organisation to gain in-depth understanding of guidelines, requirements and general expectations including current best practices and latest published regulatory and industry guidance.
  
  

• People Management responsibilities:
  
  

• To create successful work environments and provide support and guidance to your team ensuring high levels of performance
  
  

• To complete People Management tasks for your team including, but not limited to: attracting and selecting new diverse talent, onboarding and training, setting clear goals and performance expectations, providing open, timely and meaningful feedback, conducting appraisals and development discussions.
  
  

• Role model the 4i values: - Integrity – Intensity – Innovation – Involvement
  
  

EH&S:

• Understand emergency procedures and align with safe systems of work.
  
  

• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
  
  

• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules
  
  

What we need from you:

• Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Biology Quality Engineer or equivalent
  
  

• Quality Assurance, Quality Engineering/Validation experience within the pharmaceutical industry, production experience considered as an asset.
  
  

• Experience in process control, statistics, equipment validation and qualification, computer system validation and data integrity regulations
  
  

• Experience of leading, supervising and motivating a team
  
  

• You will be proactive in your approach and have the ability to manage your team and their workload, priorities and actively engage in their development
  
  

• In depth knowledge about EU and US regulatory expectations
  
  

• Experience in Six Sigma and other SPC tools, e.g. control charts
  
  

• Ability to drive functional, technical and operational excellence
  
  

• Ability to encourage and cultivate collaboration, willingness and team efficiency
  
  

• Ability to think strategically with the ability to advise the resolution of technical problems using innovative ways. Applies data integrity and ALCOA principles
  
  

• Strong communication skills: well developed verbal skills to successfully communicate to a variety of internal and external audiences, while counselling, negotiating and formally communicating views and/or technical criteria
  
  

• Ability to apply project management tools
  
  

• Proficient in use of Microsoft Office Suite and ability to master a variety of software applications
  
  

What’s in it for you:

• Competitive base salary
  
  

• Annual bonus
  
  

• Free on-site car parking
  
  

• Contributory Pension
  
  

• Private medical insurance
  
  

• Flexible benefits
  
  

About us:
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

With Thermo FisherScientific, it’s not just a career. It’s a chance torealiseyour best – professionally and personally.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminateon the basis ofrace, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.