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Director, Quality - Philadelphia Pennsylvania
Company: Disability Solutions Location: Philadelphia, Pennsylvania
Posted On: 05/07/2024
Position: Director QualityLocation: Philadelphia, PAPosition Summary: ----The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical development supply division. This individual will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, and Customer relations.The Role: -- - Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance.
- Management responsibilities include professional development, performance appraisals, and employee counselling for direct reports. Assigns work and reviews workload for all direct reports. Supervises staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
- Recommends courses of action on all management/human resources' matters, including salary administration, transfers, hiring, terminations, and position description preparation.
- Promotes, implements, and maintains quality initiatives of processes and programs to assess compliance with regulations, Global and Site SOPs, and client requirements.
- Provides to the Operational CDS and Quality organization consultation, and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials, as applicable.
- Writes and approves Quality unit SOPs and Forms, as needed. Approves Operational CDS SOPs and Forms. Supports harmonization of worldwide Quality operating procedures as needed.
- Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle.
- Other duties as assigned.The Candidate: --
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