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American Regent, Inc. · 1 month ago

QA Release Sr. Manager

New Albany, OH

Full-time

Onsite

Director/Executive

10+ years exp

American Regent, Inc. is focused on the production of pharmaceuticals and is seeking a QA Release Senior Manager to oversee the final release of products and ensure compliance with quality standards. The role involves managing QA staff, liaising with departments on quality issues, and overseeing contract manufacturing operations.

Health CareMedical

H1B Sponsor Likely

Responsibilities

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

Qualification

GMP knowledgeQuality Assurance managementLife Science degreeTechnical writingTeam-building skillsLeadership skillsOrganizational skillsConflict resolutionCommunication skills

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)

Company

American Regent, Inc.

American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.

Founded in 1967

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

H1B Sponsorship

American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (6)

2024 (10)

2023 (4)

2022 (5)

2021 (8)

2020 (9)