QA Investigations/CAPA Manager

Nature and Scope

Reporting to the QA Operations & Quality Systems Director, the Investigations/CAPA Manager focuses on overseeing the Quality investigation and CAPA related activities. This multi-disciplinary management role will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, validations, R&D, and materials at three different sites in the Columbus, Ohio area.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Provide effective supervision including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.
• Develops 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. Works with Functional Area Management to ensure Investigations are completed in accordance with company SOPs, policies, and cGMPs.
• Serves as Business Owner for the Trackwise Investigations, CAPA, and CAPA effectiveness module.
• Maintains metrics to continuously evaluate department throughput, workflows and improvement opportunities and to facilitate site cross functional goals
• Provide support for regulatory and customer audits as needed
• Knowledge of applying statistical concepts to initiate and participate in process improvement programs
• Provide leadership and direction to Quality Systems staff across multiple areas; establish and maintain performance goals, training plans, and provide regular feedback including performance plans and reviews.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.
• Leadership experience in the technical and functional management of Quality Systems activities are a plus.
• Experience across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facilities; review and release of cGMP production batches.
• Extensive knowledge of US regulations and established expertise in interpreting and applying to organization.
• Understanding of Six Sigma Basic Principles
• Excellent organizational, interpersonal and communication skills (oral and written).
• Ability to work cross functionally and collaboratively with all departments at American Regent.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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