Quality Management System Compliance Department Manager

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Job Description

About Agilent

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us.

One of our missions at Agilent is to help our customers around the world fight cancer and other life-threatening diseases. By providing our customers with the best solutions to ensure accurate and early diagnosis, we improve patient treatment and enhance survival rates.

Organizational Structure

Agilent has approximately 17,000 employees spread across Europe, the Americas and Asia Pacific. The global footprint includes sales offices, logistics centers, business facilities, and manufacturing sites in three major geographies. Agilent-s worldwide capabilities enable them to deliver high-quality solutions to their valued customers in 110 countries.

Agilent-s footprint

There are 3 Business Units (called Groups in Agilent):

  • Agilent CrossLab Group (ACG)
  • Diagnostics - Genomics Group (DGG)
  • Life Sciences and Applied Markets Group (LSAM)
     
  • Diagnostics - Genomics Group (DGG) has 6 Divisions:

  • Nucleic Acid Solution Division (NASD)
  • Biomolecular Analysis Division (BAD)
  • Pathology Division (PT)
  • Reagent Partnership Division (RP)
  • Companion Diagnostics Division (CDx)
  • Genomics Division
     
  • Manufacturing sites are not always linked directly to each division, as some sites manufacture products that cover 2 or more divisions, e.g. Glostrup site in Denmark is manufacturing primarily for PT but it also manufactures for RP and CDx. Glostrups- sister-site is based in California, and it manufactures for CDx but also for RP and PT. The whole DGG is dedicated to in-vitro diagnostics (IVD) for oncology.

    Agilent values and culture

    You will be part of a company with culture based on to the values: innovation, trust, respect, collaboration, and uncompromising integrity. Added to these traits are speed, focus and accountability to meet customer needs and build a culture of performance that draws on the full range of people-s skills and aspirations.

    We will make sure you get all the training and development opportunities you need to become the best in your field!

    The position

    The position is within DGG, Pathology/RP Division. Quality organization in PT/RP in Agilent Technologies Denmark is in a process of transformation towards a strong robust function that will support the business and assure compliance at all times.

    In your role you will be responsible to:

  • Create clear and unifying vision for the QMS Compliance department to assure product and process compliance. Show visible leadership and foster enthusiasm, commitment and dedication to the unifying vision within the team.
  • Implement necessary compliance strategies, as well as develop and oversee compliance site programs. These programs include but are not limited to Quality Management Review (QMR), training programs, and site metrics.
  • Ensure mitigation of risk, negative regulatory exposure and/or adverse impact to the business.
  • Establish, implement, and analyze Quality metrics (KPIs) and drive improvements.
  • Manage audit preparedness to comply with authority, notify bodies, customer and internal audits.
  • Manage internal site Critical Quality Issues Notification (CQIN) programs to ensure consistent and accurate messaging. Evaluate and provide improvements to other communication tools to appropriately provide compliance information to other parts of organization and global partners.
  • Ensure implementation of current applicable regulatory requirements (In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746, ISO13485, FDA CFR 21 Part 820) as well as Agilent Quality Management System
  • Translate business needs and objectives to team level, and set directions for the team accordingly
     
  • You will together with your team ensure:

  • Effectiveness of Document Management System (DMS)
  • Effectiveness of Learning Management System (LMS)
  • Trending of and follow up on: regulatory commitments (towards Notified Bodies and Health Authorities), timely product release, non-conformities, change controls, CAPAs, trainings, complaints
  • Drive continuous improvements for Quality Management System
     
  • You will have close cross-functional collaboration with among others Quality, Research - Development (R-D), Regulatory Affairs (RA) and Manufacturing.

    Qualifications

  • MSc. degree within Pharmacy, Medical Engineering, Molecular Biology or other similar natural sciences
  • Relevant years of work experience in the medical device or pharmaceutical industry
  • Relevant years supervisory experience (handling direct reports), including hiring, training, coaching and performance management activities
  • Preferably experience working with In Vitro Diagnostic and/or Medical Devices
  • Strong knowledge and understanding of standards and regulations: Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
  • Strong analytical skills with focus on finding the right solutions in compliance with the regulations.
  • High professional level in written and spoken English and Danish
  • Willingness to relocate to Denmark to be able to work together with our team
     
  • Personal skills

  • Data oriented with risk-based approach
  • LEAN mindset
  • Excellent communicating skills
  • Thrive working cross-functionally with people at all levels of the organization
  • Flexible, systematic and engaged teammate
  • Robust with a sense of urgency combined with a good sense of humor
  • Self-motivated with a high level of engagement
     
  • In addition to this we expect you to have a high drive and a proven track record of a strong leadership and communication skills, are focused on creating results (goal oriented), and are good at setting goals and direction. You have a good business understanding and are able to inspire change through clear communication, motivation, coaching, and working with other stakeholders in cross functional groups. This is a position in an international and dynamic working place with exciting challenges and opportunities.

    What we offer:

  • Outstanding company culture
  • Great environment to work
  • Career development opportunities
  • Company pension scheme and additional benefits.
     
  • Practical information

  • Deadline for application: 31. December 2022
  • Start: We will be interviewing on-going, and the position will be filled as soon as the right candidate has been identified
  • Salary: According to qualifications and Agilent defined salary range
  • 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

    Schedule

    Schedule:Full time

    Shift

    Day

    Duration

    No End Date

    Job Function

    Quality/Regulatory

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


    Quality Management System Compliance Department Manager

    Job Description

    About Agilent

    Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us.

    One of our missions at Agilent is to help our customers around the world fight cancer and other life-threatening diseases. By providing our customers with the best solutions to ensure accurate and early diagnosis, we improve patient treatment and enhance survival rates.

    Organizational Structure

    Agilent has approximately 17,000 employees spread across Europe, the Americas and Asia Pacific. The global footprint includes sales offices, logistics centers, business facilities, and manufacturing sites in three major geographies. Agilent-s worldwide capabilities enable them to deliver high-quality solutions to their valued customers in 110 countries.

    Agilent-s footprint

    There are 3 Business Units (called Groups in Agilent):

  • Agilent CrossLab Group (ACG)
  • Diagnostics - Genomics Group (DGG)
  • Life Sciences and Applied Markets Group (LSAM)
     
  • Diagnostics - Genomics Group (DGG) has 6 Divisions:

  • Nucleic Acid Solution Division (NASD)
  • Biomolecular Analysis Division (BAD)
  • Pathology Division (PT)
  • Reagent Partnership Division (RP)
  • Companion Diagnostics Division (CDx)
  • Genomics Division
     
  • Manufacturing sites are not always linked directly to each division, as some sites manufacture products that cover 2 or more divisions, e.g. Glostrup site in Denmark is manufacturing primarily for PT but it also manufactures for RP and CDx. Glostrups- sister-site is based in California, and it manufactures for CDx but also for RP and PT. The whole DGG is dedicated to in-vitro diagnostics (IVD) for oncology.

    Agilent values and culture

    You will be part of a company with culture based on to the values: innovation, trust, respect, collaboration, and uncompromising integrity. Added to these traits are speed, focus and accountability to meet customer needs and build a culture of performance that draws on the full range of people-s skills and aspirations.

    We will make sure you get all the training and development opportunities you need to become the best in your field!

    The position

    The position is within DGG, Pathology/RP Division. Quality organization in PT/RP in Agilent Technologies Denmark is in a process of transformation towards a strong robust function that will support the business and assure compliance at all times.

    In your role you will be responsible to:

  • Create clear and unifying vision for the QMS Compliance department to assure product and process compliance. Show visible leadership and foster enthusiasm, commitment and dedication to the unifying vision within the team.
  • Implement necessary compliance strategies, as well as develop and oversee compliance site programs. These programs include but are not limited to Quality Management Review (QMR), training programs, and site metrics.
  • Ensure mitigation of risk, negative regulatory exposure and/or adverse impact to the business.
  • Establish, implement, and analyze Quality metrics (KPIs) and drive improvements.
  • Manage audit preparedness to comply with authority, notify bodies, customer and internal audits.
  • Manage internal site Critical Quality Issues Notification (CQIN) programs to ensure consistent and accurate messaging. Evaluate and provide improvements to other communication tools to appropriately provide compliance information to other parts of organization and global partners.
  • Ensure implementation of current applicable regulatory requirements (In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746, ISO13485, FDA CFR 21 Part 820) as well as Agilent Quality Management System
  • Translate business needs and objectives to team level, and set directions for the team accordingly
     
  • You will together with your team ensure:

  • Effectiveness of Document Management System (DMS)
  • Effectiveness of Learning Management System (LMS)
  • Trending of and follow up on: regulatory commitments (towards Notified Bodies and Health Authorities), timely product release, non-conformities, change controls, CAPAs, trainings, complaints
  • Drive continuous improvements for Quality Management System
     
  • You will have close cross-functional collaboration with among others Quality, Research - Development (R-D), Regulatory Affairs (RA) and Manufacturing.

    Qualifications

  • MSc. degree within Pharmacy, Medical Engineering, Molecular Biology or other similar natural sciences
  • Relevant years of work experience in the medical device or pharmaceutical industry
  • Relevant years supervisory experience (handling direct reports), including hiring, training, coaching and performance management activities
  • Preferably experience working with In Vitro Diagnostic and/or Medical Devices
  • Strong knowledge and understanding of standards and regulations: Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
  • Strong analytical skills with focus on finding the right solutions in compliance with the regulations.
  • High professional level in written and spoken English and Danish
  • Willingness to relocate to Denmark to be able to work together with our team
     
  • Personal skills

  • Data oriented with risk-based approach
  • LEAN mindset
  • Excellent communicating skills
  • Thrive working cross-functionally with people at all levels of the organization
  • Flexible, systematic and engaged teammate
  • Robust with a sense of urgency combined with a good sense of humor
  • Self-motivated with a high level of engagement
     
  • In addition to this we expect you to have a high drive and a proven track record of a strong leadership and communication skills, are focused on creating results (goal oriented), and are good at setting goals and direction. You have a good business understanding and are able to inspire change through clear communication, motivation, coaching, and working with other stakeholders in cross functional groups. This is a position in an international and dynamic working place with exciting challenges and opportunities.

    What we offer:

  • Outstanding company culture
  • Great environment to work
  • Career development opportunities
  • Company pension scheme and additional benefits.
     
  • Practical information

  • Deadline for application: 31. December 2022
  • Start: We will be interviewing on-going, and the position will be filled as soon as the right candidate has been identified
  • Salary: According to qualifications and Agilent defined salary range
  • 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

    Schedule

    Schedule:Full time

    Shift

    Day

    Duration

    No End Date

    Job Function

    Quality/Regulatory

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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