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Senior Manager, Quality Compliance, RMS EMEA
2 months ago
Job Summary
The Senior Manager, Quality Compliance, RMS EMEA will be responsible for ensuring that the Inotiv RMS business complies with legal standards, company policies, procedures, and regulatory requirements.
Key Responsibilities
- Maintain and lead programs, policies, and practices to ensure compliance with industry requirements and the company Quality Management System (QMS) in EMEA.
- Maintain and monitor the QMS in compliance with ISO 9001, Home Office, and AAALAC requirements as they relate to Quality Assurance and animal welfare.
- Communicate quality and compliance risks to management.
- Support the business in meeting set closure target dates of corrective and preventive actions (CAPAs), nonconformance reports (NCRs), customer complaints records, and in maintaining current Standard Operating Procedures and Work Instructions.
- Provide guidance on generating reports and/or necessary documentation (e.g., CAPAs and change control).
- Train company personnel in quality-related functions, such as the use of audit techniques and requirements of ISO 9001 and regulatory bodies.
- Facilitate harmonization of standards worldwide and promote best practice sharing, thereby fostering the achievement of the company's mission globally.
- Monitor key performance indicators (KPIs) as they relate to quality to identify trends and recommend opportunities for improvement.
- Lead audit and inspection preparation, coordinate and facilitate external audits, lead in the resolution of audit and inspection findings, and liaise with auditing groups and audit participants through all stages of the audits.
- Analyze, evaluate, and plan methods for the solution and continuous improvement of the QMS, based on key learnings from internal and external audits, including follow-up on observations and respective actions, and maintenance of audit documentation.
- Evolving and sustaining the quality culture where quality is clearly understood and recognized as a driver to improve both the customer experience and business performance.
- Monitor and evaluate supplier performance and conduct periodic supplier audits.
- Issue and disposition Supplier Corrective Action Requests (SCARs) for suppliers failing to meet contractual service agreements.
- May manage direct reports.
Requirements
- Science degree or equivalent relevant scientific experience.
- Seven (7) or more years of experience working in a quality-related role.
- Experience in Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
- Certified Quality Auditor (CQA) preferred.
- Experience with regulatory and accrediting bodies including ISO 9001, Home Office, and AAALAC.
- Ability to travel regularly.
- Excellent computer skills including Word, Excel, PowerPoint, and Visio.
- Excellent written and verbal communication skills.
- Excellent organizational skills, analytical abilities, critical thinking, and ability to multi-task.
- Ability to work collaboratively in a teamwork environment.
- Able to manage projects and work independently.
