Overview
Perform responsibilities, as assigned, to effectively support the Inotiv RMS business in achieving compliance with legal standards, company policies, procedures, and regulatory requirements. The Senior Manager will monitor business activities for compliance with applicable rules, regulations, standards, legal client agreements, and internal company requirements. They are responsible for enforcing these rules at all levels of the business.
This is a full-time, permanent role working daily on-site at our Hillcrest location, near Loughborough.
Responsibilities
1. Maintain and lead programs, policies, and practices to ensure compliance with industry requirements and the company's Quality Management System (QMS) in EMEA.
2. Maintain and monitor the QMS in accordance with ISO 9001, Home Office, and AAALAC standards related to Quality Assurance and animal welfare.
3. Communicate quality and compliance risks to management.
4. Support the business in meeting deadlines for corrective and preventive actions (CAPAs), nonconformance reports (NCRs), customer complaints, and maintaining current Standard Operating Procedures and Work Instructions.
5. Guide the generation of reports and documentation, such as CAPAs and change control.
6. Train personnel in quality-related functions, including audit techniques and ISO 9001/regulatory requirements.
7. Promote harmonization of standards worldwide and share best practices to advance the company's global mission.
8. Monitor KPIs related to quality to identify trends and opportunities for improvement.
9. Lead audit and inspection preparations, coordinate external audits, address findings, and liaise with auditors throughout the process.
10. Analyze and improve the QMS based on audit learnings, observations, and actions, maintaining audit documentation.
11. Foster a quality culture that enhances customer experience and business performance.
12. Monitor and evaluate supplier performance, conduct supplier audits, and issue SCARs for non-compliance.
13. Perform additional duties as assigned.
Qualifications
* Science degree or equivalent scientific experience.
* Seven or more years of experience in a quality-related role.
* Experience with GLP, GMP, and GCP standards.
* Certified Quality Auditor (CQA) preferred.
* Experience with ISO 9001, Home Office, and AAALAC accreditation.
* Ability to travel regularly.
* Proficient in Word, Excel, PowerPoint, and Visio.
* Excellent communication and organizational skills, with analytical and critical thinking abilities.
* Ability to work collaboratively and independently manage projects.
In return, we offer:
* Auto-enrollment in the company pension scheme.
* Option for Bupa Healthcare enrollment.
* Discounts on health, dental, and vision care.
* Retail and tech store discounts.
* Cycle to work scheme.
* And much more!
Join our team and contribute to a dynamic environment where your skills and dedication make a difference. Apply now!
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