Job Description

Must Haves:

• Bachelor's Degree with 12+ years of experience OR Master's Degree with 10+ years of experience in a QA or GMP environment
• Experience in a QA role supporting validation, engineering, IT and change control
• Experience managing a QA organization in for both clinical and commercial operations
• Previous experience in validation or engineering
• Proven ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

Job Description:

This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, and facilities. Provide quality oversight of facility upgrades and expansions. This individual is responsible for managing the change control system. Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members. Align QA organization to meet companies strategic goals.

Responsibilities:

• Provide quality oversight into the Engineering and Validation programs supporting both clinical and commercial operations in a contract manufacturing organization (CMO) setting. Direct the review and approval processes, resulting in timely QA oversight of equipment, computer systems, utilities, facilities, cleaning and process validation. Review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program.
• Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
• Manages the change control system. Works directly with functional areas to review and approve change controls. Works to continuously improve and streamline the change control system.
• Providing guidance to QA staff on cGMP requirements for validation, facility, utility, production, equipment and computer systems. Subject matter expert accountable for site level compliance of engineering and validation of cGMP systems to the requirements of US and International regulatory agencies. Assess on an on-going basis the changing regulatory environment to establish policy, procedures and processes that drive continued cGMP compliance and business success. Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in formulating inspection responses.

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