Job Description
Pathology - Clinical Diagnostics Division
Are you an experienced manager and an inspirational leader seeking a new challenge within Quality? Do you want to make a meaningful impact in a company dedicated to advancing cancer diagnostics and improving patient outcomes? If so, we invite you to explore this exciting opportunity at Agilent.
This position serves as Site Quality Head for Agilent’s Glostrup manufacturing site, which produces products for the Clinical Diagnostics Division. The role is accountable for end-to-end manufacturing quality oversight, ensuring that all products meet stringent regulatory, compliance, and customer requirements.
You will lead the site’s manufacturing quality team and act as the Good Manufacturing Practices (GMP) and Operational Excellence (OpEx) quality leader, representing Quality on the site leadership team.
In this role you will play a pivotal role in ensuring the quality and reliability of our immunohistochemistry and in situ hybridization diagnostic products, critical diagnostics tools used globally by hospitals for precise cancer diagnosis.
About the department: The Manufacturing Quality department at Agilent plays a vital role in supporting the company’s mission to advance cancer diagnostics and improve patient outcomes. The department consists of 1 manager and 14 dedicated employees, including Quality Engineers and Batch Record Release personnel. They work collaboratively to ensure appropriate documentation of quality issues, process improvements, procedures, and release of batches from production.
The department is responsible for Quality oversight and support of NCRs, CAPAs, Design Changes, and batch record release.
You will oversee the manufacturing quality team and work closely with 3 other quality managers (Design and Product Quality), lead audit readiness for the site, and ensure site quality compliance. You will liaise with the AVP of Quality for the division and represent quality leadership at the site level. You will also work closely with fellow department managers and supporting staff to ensure seamless coordination across quality functions and drive continuous improvement.
Key Responsibilities
- Quality Leadership & Oversight
- Provide strategic and operational leadership for all manufacturing quality activities at the Glostrup site.
- Ensure compliance with global, regional, and local regulatory requirements, company policies, and GMP standards.
- Drive alignment and consistency across quality operations, including dotted-line oversight of other Quality Managers.
- Quality Operations & Systems
- Oversee core quality processes: document control, change control, training, non-conformance management, CAPA, audits, and inspections. Including hosting auditors in the front room.
- Maintain and continuously improve the Quality Management System (QMS), ensuring procedures are accurate, current, and effective.
- Establish and monitor quality metrics and dashboards; lead management reviews to assess QMS performance and resource adequacy.
- Manufacturing Quality Excellence
- Monitor audits of production areas and raw material vendors; ensure robust supplier quality oversight.
- Develop and implement standards, methods, and procedures for inspecting, testing, and validating product precision, accuracy, and reliability.
- Support complaint investigations, product investigations, field actions, and post-market surveillance.
- Strategic & Cross-Functional Impact
- Translate regulatory requirements into practical, actionable plans for manufacturing operations.
- Represent Agilent during internal and external audits, customer inspections, and regulatory interactions.
- Act as a change agent to foster a customer-focused, quality-driven culture across the site.
- People Leadership
- Select, develop, and mentor quality personnel to ensure operational excellence.
- Manage training programs and career development initiatives for the manufacturing quality team.
What Success Looks Like
- Manufacturing processes consistently deliver safe, compliant, and high-quality products.
- The site demonstrates audit readiness and strong regulatory compliance.
- Quality metrics show continuous improvement in product reliability and customer satisfaction.
- A culture of quality ownership and operation
Qualifications
- A minimum of a bachelor’s degree is required
- A minimum of 3-5 years' experience leading Quality Assurance and Quality Control in a regulated manufacturing life sciences and/or medical device or In Vitro Diagnostic company is required.
- A minimum of 5 years management experience (managing direct reports), including hiring, training, coaching, and performance management activities
- Deep knowledge of regulated healthcare environment, good manufacturing practices (GMP), and cross-functional business acumen
- Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR
- Knowledge and experience in 6 sigma and/or lean thinking – System Thinking, Value Stream Mapping, Kaizen, Problem Solving
- Experience with data collection, analysis and reporting technologies is required. Strong problem solving and analytical skills
- A visionary, strategic thinker with strong capability to collaborate and partner with peer organizations across an In Vitro Diagnostics business unit
- Proven track record of building/rebuilding organizations and driving change through transformation across Quality
- Proven success at challenging, influencing and guiding teams to optimize operations with clear business case of benefits to be delivered
- Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally
- Limited travel (domestic and international) ~10%
- Proficient in written and spoken English. Danish can be an advantage.
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:
10% of the Time
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory