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QA Operational Manager for External Manufacturing
2 months ago
Position Overview
The Quality Assurance Operational Manager plays a crucial role in overseeing the QA batch disposition process. This position is responsible for leading QA activities related to the review, applicable disposition, and archiving of batches associated with Cell & Genetic (C&G) Therapeutic programs. This includes thorough examination of batch data, records, deviations, in-process data, environmental monitoring data, QC release testing, and other quality documentation.
A significant expectation of this role is to foster collaboration and build strong relationships with both internal and external stakeholders to promote compliance and drive continuous improvement initiatives.
Key Responsibilities
- Oversee quality disposition execution for Cell and Gene (C&G) Therapy batches produced externally across clinical, launch, and commercial processes, including support for analytical laboratories and manufacturing operations.
- Manage GMP batch disposition activities, which include the review and approval of batch records, deviations, in-process data, environmental monitoring data, QC release testing, and other quality-related tasks to assess product acceptability.
- Conduct reviews of QA disposition change controls, process investigations, and Out of Specification (OOS) investigations, along with associated Corrective and Preventive Actions (CAPAs).
- Authorize Certificates of Analysis (COAs) and product labeling.
- Support technical transfers and review batch performance qualifications for process validation.
- Identify compliance risks and gaps in GMP disposition processes and implement necessary mitigating controls.
- Assist in investigating product complaints related to batches.
- Maintain and report on periodic batch record metrics and support routine/quarterly quality system data reviews.
- Lead and engage in Cell & Genetic Program and Quality projects as directed by management.
Educational Requirements
- Master's or Bachelor's degree in a biotechnology or life sciences field.
Experience Requirements
Extensive relevant experience in manufacturing, quality assurance, and/or quality control within a biotechnology or regulated pharmaceutical environment.
Knowledge and Skills
- Proven experience providing QA support to external GMP manufacturing operations.
- Demonstrated success in leading event investigations, Root Cause Analysis, and CAPA processes.
- Familiarity with network-based applications such as Oracle, TrackWise, and Veeva.
- Comprehensive understanding of cGMPs and their practical application in a pharmaceutical context, including Biotech/Cell & Gene GMP regulations and best practices.
- Knowledge of cell therapy, aseptic manufacturing technologies, analytical assays, and biologics processing.
- Membership in relevant professional societies and a strong network within the cell and gene therapy industry.
- Ability to assess quality issues and make informed decisions using a risk-based approach.
- Capacity to independently lead cross-functional teams and communicate effectively with business stakeholders.
Additional Requirements
Indicate any required certifications, licenses, or specialized training.
- Willingness to travel up to 15% may be necessary.
Work Designation:
Hybrid-Eligible or On-Site Eligible
Flexibility Status:
In this Hybrid-Eligible role, you have the option to choose:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with occasional flexibility.
