Manufacturing QA Leader: Strategy, Validation & Compliance

Allozymes; Region Hovedstaden; On-site; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Outstanding company culture

Career development opportunities

Company pension scheme

Individual bonus plan

Private health care

Medical & life insurance

Job summary

Agilent Technologies Inc. is seeking a seasoned leader to head the Manufacturing QA Qualification and Validation team at the Glostrup site.

You will guide a 7–10 person team, drive strategic QA initiatives, and ensure product quality, patient safety, and regulatory compliance across manufacturing processes for in vitro diagnostic products. You will collaborate with Manufacturing, Regulatory Affairs, R&D and Procurement, reporting to Site QA Head Denmark, Global Quality, and influencing processes

Qualifications

• 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 management

Leadership

Quality systems knowledge

Auditing experience

Education

M.Sc. in Engineering or Scientific discipline

Job description

Agilent Technologies Inc. is seeking a seasoned leader to head the Manufacturing QA Qualification and Validation team at the Glostrup site.

You will guide a 7–10 person team, drive strategic QA initiatives, and ensure product quality, patient safety, and regulatory compliance across manufacturing processes for in vitro diagnostic products. You will collaborate with Manufacturing, Regulatory Affairs, R&D and Procurement, reporting to Site QA Head Denmark, Global Quality, and influencing processes