Regulatory Compliance Lead Specialist
4 weeks ago
About Agilent
">Agilent Technologies is a world-leading life science company that develops innovative solutions for laboratory diagnostics. We are committed to improving cancer diagnostics and providing our customers with high-quality products and services.
The Role
We are seeking an experienced Compliance Operation Lead to join our team in Denmark. As a Compliance Operation Lead, you will be responsible for supporting compliance with Agilent's QMS and external requirements.
Key Responsibilities:
- 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, 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 (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, CAPA management, root cause investigation, etc.
Qualifications:
- Bachelor's degree in science or a related field is required, advanced degree in engineering, pharmaceutical, or medical field preferred.
- 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 (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.
What 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.
About the Salary:
The estimated salary range for this position is between $80,000 and $120,000 per year, depending on qualifications and experience. The actual salary may vary based on location, market conditions, and other factors.
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