Compliance Operation Lead

Job Description

Are you experienced with regulatory requirements for medical devices?

At Agilent, we develop and produce reagents, instruments, and software for in vitro diagnostic of cancer, and we are currently looking for a Compliance Operation Lead to work primarily in Corrective and Preventive Action as well in Inspection Readiness projects but also to support internal and external audits activities for our Agilent sites. This is a Global Agilent Quality position.

In this role, you will be responsible for supporting compliance with Agilent’s QMS and external requirements. You will also be responsible for driving initiatives to ensure continuous improvements of our processes as well as collaborating with international colleagues to achieve company goals.

You will partner with many stakeholders across the organization, covering but not limited to QA, R&D, RA, IT, and Marketing.

You will report to the Manager, Compliance Operations, GQRA organization.

• Support Agilent sites/divisions with a broad spectrum of Quality Operations support (CAPA, inspection/audit readiness, complex/systemic investigations, remediation).
• Serve Agilent as Global Process Owner for Nonconformity Management.
• Support Agilent sites/divisions by adhering to the Agilent QMS and applicable regulatory requirements and standards and promote overall compliance posture.
• Serve as a Subject Matter Expert for Quality & Compliance issues, lead and/or support complex investigations, and help drive risk-based actions, issue resolution, and continual improvement across the network.
• Support and/or lead cross-functional strategic projects in the compliance space, with impact on sites, divisions, or an entire business group, e.g., changes driven by remediation of complex/systemic issues, process transformation, process re-engineering, following M&A, etc.
• Lead/support the assessment and update of relevant GxP processes and systems as required.
• Support the identification, maintenance, and management of compliance activities across a Business Group within Agilent to promote a state of compliance.
• Drive CAPA and effectiveness check requirements and improvements, in partnership with applicable Business Quality groups, and ensure complex and systemic issues are addressed promptly and sustainably.
• Partner with Business Quality representatives to develop and implement corrective and preventive actions based on trends and identification of systemic issues.
• Represent QCS/Compliance as a compliance SME during external audits and Health Authority inspections as required.
• Support relevant processes and fora (e.g., Community of Practices, SME networks) that help drive upskilling and capability building across the organization.
• Support the continual improvement of processes and governance components supporting relevant compliance processes in scope, e.g., CAPA management, root cause investigation, etc.

Qualifications

Education:

Bachelor’s degree in science or a related field is required, advanced degree in engineering, pharmaceutical, or medical field preferred

Experience:

• 5+ years of industry experience in a life science environment.
• Experience must include 3+ years of experience with managing Quality Systems and/or Compliance in a life science/pharmaceutical environment (pharma, biopharma, medical device), including issue management, quality investigations, CAPA management & oversight, quality operations, etc.
• Sound knowledge of ISO9001, ISO13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, 21 CFR pt. 11. Additional experience in the biopharmaceutical environment, ICH guidelines, etc., is a plus.
• Demonstrated ability to interface with senior leaders (e.g., site leaders) and cross-functional teams, and strong proven ability to influence and drive change.
• Strong collaborative skills.
• Demonstrated ability to effectively manage multiple priorities with a sense of urgency.
• Experience in operating in a multi-disciplinary life science environment.
• Excellent written and verbal communication skills.
• Fluency in written and spoken English.

We Offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing and sustain activities.  
• A great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for labs around the world to improve cancer diagnostics.  
• A role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
• Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy and much more.

#LI-NE1

Additional Details

Travel Required

Shift

Duration

Job Function

Location: Denmark-Glostrup

Additional location:

• Option to Work Remote in Germany
• Germany-Waldbronn

Compliance Operation Lead

Job Description

Are you experienced with regulatory requirements for medical devices?

At Agilent, we develop and produce reagents, instruments, and software for in vitro diagnostic of cancer, and we are currently looking for a Compliance Operation Lead to work primarily in Corrective and Preventive Action as well in Inspection Readiness projects but also to support internal and external audits activities for our Agilent sites. This is a Global Agilent Quality position.

In this role, you will be responsible for supporting compliance with Agilent’s QMS and external requirements. You will also be responsible for driving initiatives to ensure continuous improvements of our processes as well as collaborating with international colleagues to achieve company goals.

You will partner with many stakeholders across the organization, covering but not limited to QA, R&D, RA, IT, and Marketing.

You will report to the Manager, Compliance Operations, GQRA organization.

• Support Agilent sites/divisions with a broad spectrum of Quality Operations support (CAPA, inspection/audit readiness, complex/systemic investigations, remediation).
• Serve Agilent as Global Process Owner for Nonconformity Management.
• Support Agilent sites/divisions by adhering to the Agilent QMS and applicable regulatory requirements and standards and promote overall compliance posture.
• Serve as a Subject Matter Expert for Quality & Compliance issues, lead and/or support complex investigations, and help drive risk-based actions, issue resolution, and continual improvement across the network.
• Support and/or lead cross-functional strategic projects in the compliance space, with impact on sites, divisions, or an entire business group, e.g., changes driven by remediation of complex/systemic issues, process transformation, process re-engineering, following M&A, etc.
• Lead/support the assessment and update of relevant GxP processes and systems as required.
• Support the identification, maintenance, and management of compliance activities across a Business Group within Agilent to promote a state of compliance.
• Drive CAPA and effectiveness check requirements and improvements, in partnership with applicable Business Quality groups, and ensure complex and systemic issues are addressed promptly and sustainably.
• Partner with Business Quality representatives to develop and implement corrective and preventive actions based on trends and identification of systemic issues.
• Represent QCS/Compliance as a compliance SME during external audits and Health Authority inspections as required.
• Support relevant processes and fora (e.g., Community of Practices, SME networks) that help drive upskilling and capability building across the organization.
• Support the continual improvement of processes and governance components supporting relevant compliance processes in scope, e.g., CAPA management, root cause investigation, etc.

Qualifications

Education:

Bachelor’s degree in science or a related field is required, advanced degree in engineering, pharmaceutical, or medical field preferred

Experience:

• 5+ years of industry experience in a life science environment.
• Experience must include 3+ years of experience with managing Quality Systems and/or Compliance in a life science/pharmaceutical environment (pharma, biopharma, medical device), including issue management, quality investigations, CAPA management & oversight, quality operations, etc.
• Sound knowledge of ISO9001, ISO13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, 21 CFR pt. 11. Additional experience in the biopharmaceutical environment, ICH guidelines, etc., is a plus.
• Demonstrated ability to interface with senior leaders (e.g., site leaders) and cross-functional teams, and strong proven ability to influence and drive change.
• Strong collaborative skills.
• Demonstrated ability to effectively manage multiple priorities with a sense of urgency.
• Experience in operating in a multi-disciplinary life science environment.
• Excellent written and verbal communication skills.
• Fluency in written and spoken English.

We Offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing and sustain activities.  
• A great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for labs around the world to improve cancer diagnostics.  
• A role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
• Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy and much more.

#LI-NE1

Additional Details

Travel Required

Shift

Duration

Job Function

Location: Denmark-Glostrup

Additional location:

• Option to Work Remote in Germany
• Germany-Waldbronn