Quality Assurance Manager
4 weeks ago
Reporting to the QA Operations & Quality Systems Director, the Investigations/CAPA Manager plays a pivotal role in overseeing Quality investigation and CAPA related activities.
This multi-disciplinary management position interacts with all phases of production, including manufacture of sterile injectables, laboratories, facilities/engineering, validations, R&D, and materials at multiple sites.
Key Responsibilities:
- Provide effective supervision, including individual goal setting, performance reviews, and employee development.
- Develop Quality Systems staff to maintain and enhance their skills and competencies.
- Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
- Responsible for independent execution, overall strategy, and Management of Investigations, CAPA, and CAPA Effectiveness Check Systems.
- Maintain metrics to continuously evaluate department throughput, workflows, and improvement opportunities.
- Provide support for regulatory and customer audits as needed.
Requirements:
- Bachelor's degree in Life Sciences, Quality Management, Business, or related field preferred.
- Minimum 5 years performing Root Cause Analysis in a QA, Regulatory Compliance, or Pharmaceutical Operations in a cGMP manufacturing environment or similar FDA regulated environment is required.
- Minimum 3- years work experience with quality software systems required, Trackwise experience highly preferred.
- Minimum 5 years in a supervisory or leadership role is required.
PharmaForce (Ohio) is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or any other protected characteristic.
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