Manager, QA Batch Disposition

Overview

Manager, QA Batch Disposition – Responsible for overseeing the QA Batch Disposition program in accordance with Catalent policies, standards, procedures, and Global cGMP. The role ensures batches are released meeting applicable procedures and batch records, supporting quality oversight for biologics, biopharmaceuticals, and regulated industry manufacturing.

The Manager, QA Batch Disposition reports to the Director, Quality Assurance Operations and will:

• Lead and oversee the QA Batch Disposition program, ensuring compliant and timely batch review and release activities.
• Manage 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., Track Wise).
• 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.

Candidate must meet one of the following educational and experience criteria:

• Master’s degree in a Scientific, Engineering, or Biotech discipline with a minimum of 6 years of Quality Assurance/Quality Control/Manufacturing experience within biologics, biopharmaceuticals, or a regulated industry.
• Bachelor’s degree in a Scientific, Engineering, or Biotech discipline with 8+ years of Quality Assurance/Quality Control/Manufacturing experience within biologics, biopharmaceuticals, or a regulated industry.

Additional qualifications include:

• 2+ years of progressive leadership experience, including Performance Management, Goal Setting, and Managing through Conflict.
• Demonstrable leadership experience at Catalent (participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• Strong knowledge of 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 Microsoft products, LIMS, Master Control, and Trackwise (knowledge preferred).
• Analytical and solutions‑oriented mindset with strong troubleshooting and decision‑making skills.
• Excellent communication and people leadership skills, with the ability to translate complex technical concepts for technical and non‑technical audiences.

Salary range for this position in Maryland: $145,000 – $165,000 plus an annual bonus, when eligible. Salary offered may vary based on experience and other factors.

Benefits include:

• Medical, Dental, Vision, and 401(k) from day one of employment.
• 152 hours of PTO and 8 paid holidays.
• Opportunities for continuous improvement processes and career growth within an expanding team.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit a request by email to Disabili with the job number, title, and location.