Compliance Operations Manager
4 weeks ago
About the Role
We are seeking a highly skilled Compliance Operations Lead to join our team at Agilent. As a key member of our Quality team, you will be responsible for ensuring compliance with Agilent's Quality Management System (QMS) and external regulatory requirements.
Key Responsibilities
- Support Agilent sites and divisions with quality operations, including CAPA, inspection readiness, and complex investigations.
- Serve as Global Process Owner for Nonconformity Management.
- Collaborate with international colleagues to achieve company goals and drive continuous improvements in our processes.
- Partner with stakeholders across the organization, including QA, R&D, RA, IT, and Marketing.
- Lead and support cross-functional strategic projects in the compliance space, with a focus on process transformation and improvement.
- Assess and update relevant GxP processes and systems as required.
- Support the identification, maintenance, and management of compliance activities across the Business Group.
- Drive CAPA and effectiveness check requirements and improvements, in partnership with Business Quality groups.
- Represent QCS/Compliance as a compliance SME during external audits and Health Authority inspections.
Requirements
- 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, with 3+ years of experience 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, and other relevant regulatory requirements.
- Demonstrated ability to interface with senior leaders and cross-functional teams, and strong proven ability to influence and drive change.
- Strong collaborative skills and excellent written and verbal communication skills.
- Fluency in written and spoken English.
What We Offer
- A dynamic and inclusive work environment with a team of passionate colleagues.
- A great opportunity to make a significant impact and develop your skills in a world-class company.
- A competitive salary and benefits package, including Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, and Physiotherapy.
Travel and Work Arrangements
This role includes occasional travel and a full-time weekly schedule with the option to work remotely.
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