Job Description
Position Summary:
This position is responsible for assessing the inputs (i.e. technical documentation) associated with manufacturing and analytical testing processes in order to disposition batches in accordance with cGMP. The position requires significant attention to detail and the ability to make critical GMP decisions regarding the impact of atypical or extensive events for batches manufactured at BVL. The incumbent will also be responsible for mentoring of the Auditor II associates in the preparation and detail of batch disposition summary packages.
Duties and Responsibilities:
The Product Disposition Manager applies expert judgment to ensure that all aspects of the manufacturing process and analytical testing have been fully evaluated regarding overall impact relative to final product batch disposition. Assesses the results of environmental and physical monitoring conditions relative to product impact and will collectively evaluate/assess the deviations and events associated with the preparation, manufacturing and testing of the product to provide a holistic overview regarding potential impact to the product. In no case will product be deemed releasable if questions regarding potency, purity, safety, stability, identity are not satisfactorily addressed in order to successfully mitigate any product or compliance risk.
Advises the Quality Operations Management team of issues within the batch that may pose significant compliance risk to the product, customers, and BVL.
Determines and justifies BVL disposition of product as releasable and/or as rejected in accordance with cGMP’s and specifications.
Active Participant on the Quality Council with the authority to convene the Quality Council to discuss critical batch release issues which may have a global impact on the facility. Lead efforts for continuous improvement in the batch documentation process to meet batch disposition commitments relative to site metrics.
Product disposition activities require daily coordination with Manufacturing, QA documentation and Materials Management. Work priorities must be negotiated and communicated throughout the organization. Recommendations for product release, hold, and lot rejection must be communicated immediately (with justification) to senior management and the client.
Ensures that the batch disposition process is executed (i.e. released, hold or rejected) in a timely and compliant manner for batches requiring this extensive level of review.
Reviews summaries of batch related documentation (i.e. records, Environmental Monitoring data packages, analytical data, labeling, process validation, etc) for compliance with all filed regulatory specifications and manufacturing commitments, cGMPs and internal documented processes (i.e. SOPs). Where necessary initiates detailed reviews of areas to ensure any identified issues are adequately addressed from a global perspective as well.
Reviews third party contract manufacturing records for compliance with established requirements and directs communication of issues directly or via project managers.
Communicates all issues, corrections needed and documentation required to appropriate departments throughout BVL. Interacts with each applicable department to correct errors and resolve issues. Responsible for providing feedback to area managers as to the quality of the documentation provided for batch disposition. Develop metrics on batch disposition process.
Requirements:
Bachelor of Science degree in Chemistry, Microbiology or equivalent discipline.
Minimum 5 years of prior progressive experience in cGMP pharmaceutical manufacturing operations or quality assurance. Experience must include at least 3 years of management responsibility within an aseptic pharmaceutical fill/finish facility or equivalent.
Strong decision maker capable of passing expert judgment over atypical events and establishing appropriate cGMP decisions regarding batch disposition and ultimate release to market.
Must have significant GMP experience in the review/approval of environmental and analytical data as well as complete batch documentation. The incumbent will also be required to have experience participating in corrective action / preventative action investigation and resolution programs, lot release record review, and SOP review.
Requires experience with global compliance regulations as they relate to the manufacturing and release of product to market.
Excellent reading, evaluation and organizational skills.
Proficiency in the use of Microsoft Office products including Word, Access, Excel, and Outlook and other software program relevant to the job.
Good communication skills, both oral and written, with the ability to work across all levels of the organization.