Compliance Operations Lead
2 weeks ago
Description
We are seeking a skilled Compliance Operations Lead to join our team at Agilent. As a Compliance Operations Lead, you will be responsible for supporting compliance with Agilent's Quality Management System (QMS) and external requirements.
In this role, you will drive initiatives to ensure continuous improvements of our processes, collaborate with international colleagues to achieve company goals, and partner with stakeholders across the organization.
You will support Agilent sites/divisions with Quality Operations support, including 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.
- 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.
- Support and/or lead cross-functional strategic projects in the compliance space, with impact on sites, divisions, or an entire business group.
- 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.
We offer 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.
Our team is passionate about delivering high-quality work, and we are looking for a dedicated and skilled professional to join us. If you are experienced with regulatory requirements for medical devices and are passionate about quality and compliance, we encourage you to apply for this exciting opportunity.
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.
- Sound knowledge of ISO9001, ISO13485, MDSAP, IVDR, 21 CFR 820, 21 CFR 210/211, 21 CFR pt. 11.
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