QA Manager Site Denmark, Global Quality

DK05 DAKO Denmark R&D & Manufacturing; Glostrup Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Benefits offered by this job

Outstanding culture

Career development

Pension & bonus plans

Private health care

International environment

Job summary

Agilent Technologies Inc. in Denmark is seeking a Manager in Manufacturing QA to lead a 7-10 person team of QA engineers and specialists.

You will ensure quality and regulatory compliance across manufacturing processes for in vitro diagnostic devices and accessories used in cancer diagnostics. Reporting to the Site QA Head Denmark, Global Quality, you will drive qualification and validation, audits, and change control, while coordinating with Manufacturing, Regulatory Affairs, R&D and

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.

Responsibilities

• Lead and develop the Manufacturing QA qualification and validation team, including talent development and performance management.
• Translate business needs to team level and set directions for the team.
• Represent QA management in strategic projects at the DK site and ensure compliance with EU IVDR and ISO 13485.
• Lead internal and external audits and act as Deputy Management Representative for Site Glostrup.
• Drive continuous improvement of systems and processes and oversee Change Control, qualification/validation of equipment, processes and methods.

Skills

Team leadership

Regulatory compliance

Quality Systems

Audits

Change control

Risk management

Education

M.Sc. degree or equivalent

Job description

Job Description As Manager in Manufacturing QA, you will be leading a team 7-10 of highly engaged and skilled QA engineers and specialists to ensure quality as well as regulatory compliance within manufacturing processes in production of intermediates to finished products of our Invitro Diagnostic medical devices and accessories. You will work as part of the Glostrup QA management team in close collaboration with stakeholders include Manufacturing, Regulatory Affairs, Research and development and Procurement, covering processes from design transfer of new products to release of our marketed products for invitro diagnostic of cancer. The role offers a unique combination of strategy, execution, transformation, and people leadership, providing significant visibility and influence across the DK site and the broader Agilent enterprise to align processes across manufacturing sites.

Position Summary We are seeking an experienced and inspirational leader to head the Manufacturing QA Qualification and Validation team. You will be representing QA management in project steering groups as well as setting direction and coaching team members to ensure product quality, patient safety and compliance to internal and external requirements. You will also be responsible for driving strategical projects in the QA organization and across the site. Furthermore, you must ensure continuous coordination, alignment and good collaboration with relevant stakeholders within the organisation to enhance the efficiency in the daily work and the quality of processes and documentation. This position reports to the Site QA Head Denmark, Global Quality.

Job 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.

Qualifications Qualifications Education: M.Sc. degree or equivalent university degree in Engineering or Scientific discipline. Experience: 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.

We offer:

• Outstanding company culture
• Career development opportunities
• Company pension scheme, individual bonus plan, private health care, medical & life insurance.
• A position within an internationalorganization, offering a dynamic working environment, with exciting challenges and opportunities

Additional Details This job has a full time weekly schedule. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws. Travel Required: Occasional Shift: Day Duration: No End Date Job Function: Quality/Regulatory Graduate and Student Career Site Visit our career site and learn more about Agilent Watch our video playlist to get a glimpse of life at Agilent! As a global leader in laboratory and clinical technologies, we are passionate about bringing great science to life. Our commitment to quality and innovation supports cutting-edge life science research, patient diagnostics, and ensures the safety of water, food, and pharmaceuticals. As scientists and clinicians pursue small, everyday advances and life-changing discoveries, we provide trusted answers to their most critical questions and challenges. Leveraging more than 50 years of expertise, we create advanced instruments, software, and consumables supported by teams of highly skilled and knowledgeable people. With 18,000 employees around the world, our global reach and comprehensive solutions provide the most reliable and accurate results, as well as optimal scientific, economic, and operational outcomes. We work collaboratively with our customers on their journey to make a real difference in human lives. Our culture is founded on trust, respect, and uncompromising integrity, and we pride ourselves on being a dynamic and inclusive workplace that celebrates diversity and fosters innovation. We can’t wait for you to join us as we continue our mission to improve the world around us.

Information about Agilent is available at Agilent.com.