Sr Dir Quality

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

SUMMARY OF POSITION:

The Sr. Director, Quality is responsible for a broad range of duties/functions that includes all Quality functions at the St. Louis Plant, and the Centers of Excellence for Microbiology, Elemental Impurities, and Validation, to support the Generics Business

The Sr. Director, Quality is responsible for ensuring cGMP compliance and product quality at the Saint Louis, MO facility while supporting broader site quality initiatives aligned with company objectives. This role provides strategic leadership in the development, implementation, and oversight of site quality systems to ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality.

The Sr. Director leads and mentors quality assurance and quality control teams, oversees daily quality operations, and serves as a key partner to site leadership by providing guidance on quality and compliance across the organization.

Responsible for and will develop, establish and maintain quality systems programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. May serve as liaison between the company and the various governmental agencies.

Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues. Establish and ensure compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error, salvage, spoilage reports and process statistics for significant findings and conclusions;

work with Research and Development during new product start-ups, and establish key checkpoints for new products and processes

The Sr. Director is responsible for Centers of Excellence for Microbiology, Elemental Impurities, and Validation to support the Generics Business. Will develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service. Establishes and maintains positive and mutually rewarding relationships with internal and external customers of the department. The Sr. Director will be also responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures.

• Manages all aspects of plant Quality Systems including, CAPA, Supplier Quality, Change Control, in-process Quality Assurance, Quality Control, complaint management and validation functions.

• Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies. Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant.

• Responsible to make fact-based, scientifically sound, quality decisions regarding products manufactured…