Senior Quality Systems Manager
3 days ago
Job Description
We are seeking an experienced Senior Quality Systems Manager to oversee our Quality investigation and CAPA related activities. This role will involve interacting with various departments, including manufacture of sterile injectables, laboratories, facilities/engineering, validations, R&D, and materials at multiple sites in the Columbus, Ohio area.
Key Responsibilities:
- Providing effective supervision, including individual goal setting/performance reviews, employee development, conflict resolution, and communication planning.
- Developing Quality Systems staff to maintain and enhance their skills and competencies.
- Performing duties in accordance with American Regent Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
- Leading the independent execution, overall strategy, and management of Investigations, CAPA, and CAPA Effectiveness Check Systems.
- Maintaining metrics to evaluate department throughput, workflows, and improvement opportunities.
- Supporting regulatory and customer audits as needed.
Requirements:
- Bachelor's degree in Life Sciences, Quality Management, Business, or a related field (preferred).
- Minimum 5 years of experience performing Root Cause Analysis in a QA, Regulatory Compliance, or Pharmaceutical Operations environment (cGMP manufacturing).
- Minimum 3 years of work experience with quality software systems required; Trackwise experience is highly preferred.
- At least 5 years of supervisory or leadership experience is required.
Preferred Qualifications:
- Leadership experience in technical and functional management of Quality Systems activities.
- Experience across multiple areas, including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities.
- Extensive knowledge of US regulations and established expertise in interpreting and applying them.
- Understanding of Six Sigma Basic Principles.
About Us:
American Regent Inc. celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
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