Manager, Quality Assurance

Overview:

The Manager is expected to work on site daily at the Horst site. Must be fluent in both Dutch and English.

Responsibilities:

• Managing programs to ensure compliance with regulatory and statutory requirements
• Preparing and revising documents that support regulatory and statutory requirements
• Applying rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
• Tracking and trending performance of quality systems (i.e., customer complaints) and preparing and presenting status reports for key performance indicators to management
• Facilitating root cause analysis on significant customer complaints and/or complaint trends
• Assess nonconformance reports with regards to the level of risk to product quality
• Analyse trend data to identify key areas of opportunities that impact product quality
• Facilitating and reviewing customer correspondence associated with complaints
• Reviewing and approving complaint investigations and associated RCAs and CAPAs
• Leading and participating in Continuous Improvement projects
• Participating in the Document Control process
• Reviewing and approving changes to controlled documentation (policies, procedures, etc.)
• Leading and participating in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
• Leading and participating in customer, supplier, internal and regulatory audits
• Performing compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
• Collaboratively working with Operations and other functional departments to address audit findings by established deadlines
• Collaborating cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
• Conducting training for new hires as required
• Promoting and complying with Inotiv’s quality assurance procedures
• Promoting and complying with Inotiv’s health and safety procedures
• Fulfilling any other assigned duties that may be required by Envigo
• Managing direct reports
• Perform other duties as assigned

Qualifications:

• B.S./B.A. required in technical degree; 3-5 years of experience working in Quality Assurance-related area required
• Experience with Quality Management System software
• Excellent Excel skills and/or other data analysis tools to create and analyse data (pivot tables, graphs)
• Auditing experience
• Experience with performing Root Cause Analysis and Change Control
• Excellent computer skills including Word, Excel, Power Point and Visio
• Excellent written and verbal communication skills
• Excellent organizational skills, analytical abilities, and ability to multi-task
• Ability to work collaboratively in a teamwork environment
• Ability to be a self-starter and work independently
• Fluent in both Dutch and English, spoken and in writing
• Excellent interpersonal and customer service skills; builds rapport to influence message, acceptance and understanding
• Excellent organizational skills and attention to detail
• Actively seeks opportunity to develop own skills and knowledge
• Gives practical support and assistance to enable individuals to get the job done
• Discusses process improvement opportunities within own department and across other areas
• Demonstrates effective use of time and resources
• Routinely meets agreed deadlines

• Experience in the life sciences related industry
• Experience working around laboratory animal models
• Experience in Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)
• Certified Quality Auditor (CQA)
• Lean Six Sigma Quality-related certification
• AALAS Certification
• Experience with JD Edwards

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