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Global Quality Systems Manager
2 months ago
The Global Quality Systems Manager plays a pivotal role in establishing and driving a culture of quality at Indivior. This tactical, hands-on position reports to the Head of Quality Systems & Operational Excellence (OPEX) and is responsible for managing, complying with, and improving specified elements of Indivior's Global Pharmaceutical Quality System.
Key Responsibilities:- Champion the establishment and lifecycle management of the INDIVIOR Pharmaceutical Quality System (PQS).
- Ensure quality processes are effective, enabling commercial product release supporting patient markets supplied globally.
- Collaborate with cross-functional teams to drive compliance and improvement initiatives.
- Develop and implement Lean Six-Sigma methodologies and project management techniques to enhance quality processes.
- Work with the QS & OPEX team to design, standardize, simplify, improve, and communicate the PQS to follow all applicable international regulations and standards.
- Identify and report process and IT system metrics and trends to drive compliance.
- Act as process owners for named processes and provide direct oversight for PQS processes.
- Escalate product and process quality issues and identified risks to the QLT and SLT teams as appropriate.
- Support the Process Owner in ensuring key changes in regulations and standards are effectively communicated and incorporated into the PQS for continual improvement.
- Bachelor of Science degree in a life science or engineering (preferred).
- Experience in establishing quality processes and systems in the pharmaceutical, biopharma, or medical device industries.
- Excellent working knowledge of CI tools and techniques.
- Project Management experience or certification.
- Green Belt Certified in Lean Six-Sigma.
- Intermediate to advanced level of practical understanding of drug product/device regulatory requirements.
- Strong interpersonal and communication skills.
- Able to deliver concise written or oral summaries to senior management.
- Ability to deliver effective presentations and updates.
- Influencing skills in areas with no direct reporting authority.
- Indivior offers a comprehensive benefits package, including 3 weeks' vacation, 401(k) and Profit Sharing Plan, U.S. Employee Stock Purchase Plan, and more.
