Manager, QA Batch Disposition

Catalent•Harmans, MD

1d•Onsite

About The Position

Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products. The Manager, Quality Assurance (“QA”) Batch Disposition is responsible for providing quality oversight for the “QA Batch Disposition” program in accordance with Catalent policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring batches are released meeting the applicable procedures and batch records. The Manager, QA Batch Disposition reports to the Director, Quality Assurance Operations.

Requirements

Master’s degree in a Scientific, Engineering, or Biotech discipline with a minimum of 6 years of Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor’s degree in a Scientific, Engineering, or Biotech discipline with 8+ years of Quality Assurance/Quality Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
2+ years of progressive leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
Familiarity with electronic systems, including developing and producing reports using Microsoft products.
Analytical and solutions-oriented, with strong troubleshooting and decision-making skills, and the ability to deliver results in a fast-paced, client-driven, deadline-oriented environment.
Excellent communication and people leadership skills, including the ability to translate complex technical concepts for technical and non-technical audiences and to coach, mentor, and develop employees.

Nice To Haves

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
LIMS, Master Control and Trackwise knowledge preferred.

Responsibilities

Lead and oversee the QA Batch Disposition program, ensuring compliant and timely batch review and release activities.
Manage the day-to-day operations of the QA Batch Disposition team, including workload planning, prioritization, and resource allocation.
Develop, coach, and manage team members, ensuring appropriate training, performance management, engagement, and adherence to safety and quality standards.
Provide QA leadership and oversight for manufacturing operations, ensuring compliance with cGMP requirements, approved procedures, and batch records.
Monitor and oversee real-time batch record review activities, escalating issues as needed to support product quality and release timelines.
Facilitate cross-functional meetings and collaborate with Manufacturing, Operations, and key stakeholders to resolve batch release roadblocks and achieve business objectives.
Drive quality culture initiatives, continuous improvement efforts, and Practical Process Improvement (PPI) activities to enhance efficiency and effectiveness of quality systems.
Ensure quality events, deviations, investigations, and corrective actions are appropriately documented, managed, and closed within quality management systems (e.g., TrackWise).
Develop, maintain, and improve quality procedures, KPIs, and performance metrics to support compliance and operational excellence.
Partner with Human Resources and site leadership to attract, develop, and retain talent while fostering a collaborative, high-performing team environment.
Other duties as assigned by management.