QA Manager Site Denmark, Global Quality

Allozymes; Region Hovedstaden; Vor Ort; DKK 900.000 - 1.300.000; Vollzeit

Benefits dieser Stelle

Outstanding company culture

Career development opportunities

Company pension scheme

Individual bonus plan

Private health care

Medical & life insurance

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

People management

Leadership

Quality systems knowledge

Auditing experience

Ausbildung

M.Sc. in Engineering or Scientific discipline

Jobbeschreibung

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

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 international organization, offering a dynamic working environment, with exciting challenges and opportunities

Questions

For any questions, please contact the hiring manager, Asger Vig via phone [phone] or email at [e-mail] .

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