Sr QA Manager

Job Description

Job Title: Sr. Manager, Quality Assurance

Location: Roskilde, Denmark

When you are part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Job summary

We are looking for a forward-thinking Senior Quality Assurance Manager that provides leadership of the Quality function to our site in Roskilde, Denmark. This key leadership position is accountable for improving product and process quality, compliance and improvements of site quality management system, managing customer expectations, driving organizational effectiveness, proactively engaging with business leaders, and driving to transform customer experience and to achieve business goals.

About the role

• Sets the overall quality strategy for the Roskilde site that supports growth and compliance readiness.
• Actively participates in quality improvement projects to move the organization from QC to QA. Carries out leadership responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding, discipline of employees; addressing complaints and resolving problems.
• Provides leadership and mentor Operations Quality, Quality Systems, Technical Quality functional teams. Manages (3-5 direct reports; 35+ indirect).
• Lead, maintain and create efficiencies in the Quality Management System to fulfill regulatory requirements and standards (e.g. 21 CFR 820, ISO 9001 / 13485 / 11137, MDD and IVDD).
• Assure management reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/actions. Works closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained.
• Creates cross functional collaboration and influences all business functions to apply appropriate quality tools including Lean, Six Sigma, TQM principles, business process improvement methods and statistical methods (e.g. design of experiments, statistical process control).
• Maintains alliance with local and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.
• Effectively manages Corrective and Preventive Action System. Works with various departments to identify actions required to assure corrective and preventative actions are properly documented and follows up to initiate and monitor timely completion of actions.
• Oversees the Internal Audit program assuring compliance with regulatory standards. Coordinate and participate in any external or customer audits.
• Set site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.
• Manages Key Quality Business Metrics and Department Metrics.
• Act as the site Quality Representative with third party agencies, regulatory agencies and any government agency.
• Other duties may be assigned, as required.

What will you need?

• Quality management experience, ideally in an MDD, IVDD, ISO 9001 and ISO 13485 certified medical device manufacturing company.
• Hands-on experience in managing CAPA system and SPC programs.
• Experience with FMEA and other risk management tools
• Experience with problem-solving techniques such as PPI, 8D, DMAIC, PPS
• Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team.
• 5%-10% travel requirement
• Bachelor’s Degree in Engineering or Science (or equivalent experience)

What is in it for you?

We are a Fortune 500 company and maintain a pay-for-performance culture; we provide an extensive onboarding program and continued training throughout your career; access to the most important scientific research laboratories in the territory; we offer flexible work arrangements and many personal growth opportunities within a multifaceted organization.

• Excellent basic salary plus bonus
• Private healthcare
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

If you are an individual with a disability who requires reasonable accommodation to complete any our application process, click here (https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility) for further assistance.

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