QA Validation Manager

at  Thermo Fisher Scientific

POSITION SUMMARY:

Reporting directly to the senior QA Manager, the jobholder is responsible for providing effective leadership and quality oversight for all aspects of the validation and qualification process and activities across site. This includes Equipment, Facility, Utility, Cleaning, Computer system & shipper qualification activities.
The role may also require involvement in executing and reviewing validation and qualification activities.
The role will be responsible for assuring compliance with all relevant legislation and maintaining a best in class quality system ensuring that Quality Assurance is integral to the business strategy (3-Year outlook) and ‘fit for purpose’ in delivering on Business Goals.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Extensive knowledge of GMP environments.
• Teamwork especially in a matrix management organisation.
• Ability to influence across functions across Fisher sites and across companies to achieve objectives.
• Process analysis skill suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit.
• Experience gained at a middle management level within a pharmaceutical environment.
• Flexible and adaptable, with strong customer management skills. Must be highly responsive whilst maintaining strategic direction. Needs to be comfortable with ambiguity.
• Able to analyse problems and define solutions.
• Good interpersonal skills both internally and externally.
  Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

• To ensure that all routine requalification and new validation activities are carried out in accordance to the Validation Policy and Site Validation Master Plan and in line with documentation timelines.
• To own procedures to be used on validation exercises and projects according to cGMP and Regulatory requirements and to manage the overall implementation of these exercises and projects including execution of protocols where required.
• To chair Site Validation committee meetings and produce the minutes.
• To track, trend and report on all validation/qualification and change control related metrics monthly and quarterly for management review.
• To investigate, develop and implement improvements to validation templates and procedures.
• To advise on validation requirements vital to maintain compliance with current GMP and regulatory requirements across site.
• To collaborate closely, co-operate and train other departments to carry out validation process improvements and changes required to meet cGMP and regulatory requirements.
• To ensure compliance with Health and Safety and Environmental requirements.
• To propose and agree Revenue and Capital Budgets necessary to carry out the agreed validation programme and to operate within those agreed budgets.
• To act as Qualification and Validation SME in client audits and regulatory inspections.
• Manage a team of people both reporting directly and indirectly into this role.
• Other tasks as necessary to maintain the effective functioning of the Validation teams across site as required by the senior QA Manager.
• To ensure the team provides quality management of the change control process and Maximo equipment maintenance system.
• To participate and chair where required the weekly change control meetings.
• Act as Delegate for Senior QA Manager as required.
• To undertake additional duties as directed and agreed with the Senior QA manager.