Manufacturing QA Manager — Lead, Develop & Ensure Compliance

agilent; Glostrup Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Benefits offered by this job

Outstanding company culture

Career development opportunities

Company pension scheme

Private health care, medical & life保险

Job summary

Agilent Technologies Inc. in Denmark seeks an experienced Manager to lead the Manufacturing QA Qualification and Validation team, ensuring product quality and regulatory compliance across manufacturing processes for in vitro diagnostic products.

You will report to Site QA Head Denmark and drive strategic QA initiatives at the Glostrup site. The role combines leadership, strategy, and hands-on QA activities, with collaboration across Manufacturing, Regulatory Affairs, R&D and Procurement to

Qualifications

• M.Sc. degree or equivalent university degree in Engineering or Scientific discipline.
• Minimum 5 years of experience in the medical device or pharmaceutical industry.
• Strong knowledge of quality system standards (ISO 13485, FDA 21 CFR part 820, MDSAP and IVDR).
• Preferably experience with people management, including hiring, coaching, and performance management activities.

Responsibilities

• Lead and develop the Manufacturing QA qualification and validation team, including talent development, motivation, performance management, ensuring the right capacity and competences, succession planning and prioritization of work.
• Translate business needs and objectives to team level and set directions for the team.
• Partner with our Line-of business such as the Manufacturing division to align priorities, ensure resources, resolve execution challenges, and enable project deliveries as well as continuous changes of manufacturing equipment and processes.
• Represent QA management in strategic projects at the DK site.
• Ensure compliance with EU IVD Regulation, ISO 13485, and other relevant standards and regulations as well as Agilent QMS.
• Participate in and lead internal and external audits as needed.
• Take responsibility as Deputy Management Representative for Site Glostrup.
• Lead and coach your team to ensure: Continuous improvement of systems and processes.
• Management of the Change Control process.
• QA responsibility of qualifications and validations of among others equipment, processes, test methods, cleaning, and software.
• Adequate process monitoring of and Risk management in manufacturing processes.
• Inspection and audit readiness.

Skills

People leadership

Cross-functional collaboration

Regulatory compliance

Quality management

Education

M.Sc. degree or equivalent in Engineering or Scientific discipline

Job description

Agilent Technologies Inc. in Denmark seeks an experienced Manager to lead the Manufacturing QA Qualification and Validation team, ensuring product quality and regulatory compliance across manufacturing processes for in vitro diagnostic products.

You will report to Site QA Head Denmark and drive strategic QA initiatives at the Glostrup site. The role combines leadership, strategy, and hands-on QA activities, with collaboration across Manufacturing, Regulatory Affairs, R&D and Procurement to