About the role

Role 1: QA Batch Release Manager

Role Summary:

Primarily responsible for managing the daily activities of the QA Batch Release as it relates to releasing commercial batches to market. This includes final approval of audited batches records prior to release, and revising standard operating procedures, communicating with various departments when exceptions are initiated or being resolved. Develop succession planning for the Batch Release Quality Unit.

What You Will Achieve

In this role, you will:

Lead and provide Oversight for Batch Release activities to ensure compliance to cGMP systems and procedures.
Organize the workflow of the QA Batch release department and communicate effectively with the team and management regarding the progress and issues.
Ensure that support required for approval of investigation are provided and disposition is performed against the specified batches.
Ensure any deviations and change control associated with the product are communicated effectively and timely for disposition decision.
Work with Responsible persons and the Site Quality Assurance Deviations/ Investigations, CAPA, change controls, Material management, Laboratories, Operations, Regulatory Assurance and Validations etc. to ensure all batches requiring restriction are identified, and upon, approval of requirements, all restrictions are lifted.
Work with Quality Operations teams to ensure compliance with respect to materials, area, equipment, monitoring conditions, people, processes, and procedures associated with the Batch manufacturing.
Work with Manufacturing/ Operations to resolve questions and/or determine if exception reports (ERs) are needed.
Develops goals and objective for the batch release team to obtain maximum efficacy from departments including delivery of cost saving initiatives.
Implement and maintain processes and systems to ensure adequate Management review and the identification of follow-up actions
Identify and implement potential improvements in processes or products, taking calculated risks to develop innovative ideas
Manage the performance of direct reports through goal setting, coaching, and ongoing assessment, recognizing the need for development and creating development plans
Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view, while sharing own perspectives and rationale

Here Is What You Need (Minimum Requirements)

B. Pharm/M. Pharm / M.Sc. in Sciences with preferably 10 + years of experience in Manufacturing Quality/Production or in Quality Assurance of a sterile dosage manufacturing facility
Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry
Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
Strong collaboration, relationship management, and interpersonal skills
Strong people management experience
Excellent written and oral communication skills
Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent

Bonus Points If You Have (Preferred Requirements)

Master's degree with a solid understanding of sterile dosage manufacturing facility
Strong analytical and problem-solving skills
Ability to work independently and make decisions
Excellent organizational and time management skills
Experience in interfacing with regulatory agencies during audits
Ability to drive continuous improvement initiatives
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use