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Manager of Quality Assurance and Compliance
2 months ago
We are seeking a highly experienced Senior Manager to lead our R&D Deviation and CAPA Management team. As a key member of our organization, you will be responsible for ensuring the highest level of quality and compliance in our operations.
Key Responsibilities- Lead and facilitate Quality Event Investigations and subsequent CAPA development in accordance with defined timelines and in collaboration with subject matter experts.
- Build, deploy, and reinforce learning tools and materials to support quality event management capability development.
- Oversee the standard and timeliness of deviation and CAPA completion.
- Work with business process owners to identify issues and improvement requirements and lead those improvement initiatives.
- In support of the quality management system module leads, maintain records of issues, enhancement requests, and support the implementation of system changes.
- Administer notification to management and escalation process.
- Participate in risk assessments and act as risk facilitator.
- GxP experience is preferred.
- 10+ years' experience in Biopharma experience.
- 6+ years managing investigations (deviations, CAPA, etc).
- Experience writing investigations.
- Experience managing RCA.
- Self-motivated.
Innova Solutions offers a comprehensive benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings account (HSA), flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves (as required by law), and an Employee Assistance Program (EAP).
