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Manager Manufacturing Investigation Report (MIR)/Compliance

Responsibilities:
• Manages compliance related activities for the Investigations Personnel assigned to the operational department. Assigns and tracks progress of work against assigned due dates, mentors and trains personnel and provides feedback on performance per Performance Management process or as required. Coordinates with the training manager to assure that training curriculum for staff is current and that training is conducted timely and effectively. Participates in the interviewing and hiring of personnel responsible for the Investigation process. Verifies that these individuals have the required training identified in their curriculum and that performance objectives are written to reflect their responsibilities and are aligned with site objectives.

o The primary activities for three Quality Systems managed by the Manager, MIR/Compliance in Pearl River Biotech department are the following:

o Manufacturing Investigation Processes: Manages the investigations within their assigned department in Pearl River Biotech. Assures that investigations and commitments from investigations are completed in compliance with procedures and cGMPs. Through monitoring, coaching, training, and collaboration, ensures that investigations and commitments contain accurate technical information and are completed by the assigned due dates. Verifies that an adequate investigative approach is followed to reach the root cause for the deviation. Investigates and reviews investigations. When necessary, elevates investigations concerns to his/her supervisor.

o Commitment Processes: Manages the commitments within their assigned department Pearl River Biotech. Assures that commitments from MIRs are completed in compliance with procedures and cGMPs. Through monitoring, coaching, training, and collaboration, makes sure that commitments contain accurate technical information and are completed by the assigned due dates. May investigate and review investigations. When necessary, elevates investigations concerns to his/her supervisor.

o Develops and maintains systems for coordinating, tracking, and follow-up on all activities related to Investigations and Commitments. Communicates timely feedback to PPU Management regarding any situation that may result in a compliance issue. Develops metrics and creates reports that communicate overall compliance of the investigation progress in the PPU.

• Manager will participate as required as a contact person during inspections and audits. The Manager, MIR/Compliance may escort the inspector/auditors during the inspection process as required.

Qualifications:
- Bachelor's degree, preferably in a technical/scientific discipline, is required. An advanced degree is a plus
- Training in QA, QC, manufacturing processes, camp's, and relevant site Sop's

Research and industry experience in products produced at site, experience in dealing with Regulatory compliance. 5-7 years previous pharmaceutical industry experience. 3-5 years of supervisory experience. Experience in problem solving, negotiations, presentation and supervision of a multi-layered organization. Experience in 3 or 4 of the following: Manufacturing Documentation Quality Systems (Manufacturing Investigations), QA/QC/Regulatory, Aseptic Processing, Technical Writing and Compliance.

Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.

Manager, MIR/Compliance for Pearl River Biotech is responsible for performing the functions associated with managing compliance quality systems such as the Manufacturing Investigations process, Corrective Action Process through commitments and Corrective Action/Preventive Action (CAPA).

This position provides leadership to ensure timely closure of investigations and commitments resulting from investigations. This position directly supervises a group of Investigators. This position assures effective and efficient cross-functional team meetings. Establishment of performance goals and strict adherence to cGMP's is required.

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