Job Description

Nature and Scope

Reporting to the QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent 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.

• Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases.
• Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements.
• Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners.
• Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director.
• Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations.
• Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management.
• Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel.
• Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management.
• Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold.
• Ensures Quality Assurance goals and objectives are identified and met
• Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director
• Provide effective leadership 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.
• 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.

• Bachelors' degree in Life Science or equivalent course of study is required.
• 10 years progressive experience in QA Pharmaceutical environment required.
• 5-10 years management experience required.
• Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices.
• Excellent oral and written communication skills including strong technical writing skills.
• Strong organizational skills, planning skills and team-building.
• Ability to work independently and deliver timely results.
• Ability to lead cross functional teams, resolve conflicts and disagreements.
• Ability to travel between each of the Ohio facilities (in the greater Columbus area).

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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