Manager, QA Batch Disposition

Catalent

Harmans, MD Onsite Quality Assurance Methods

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About this role

Manager, QA Batch Disposition

Position Summary:

Work Schedule: Monday – Friday, 8am – 5pm.
100% on-site

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.

The Role

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.

The Candidate

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.
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.
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. LIMS, Master Control and Trackwise knowledge preferred.
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.

The anticipated salary range for this position in Maryland is $145,000 - $165,000 plus an annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should Join Catalent

Potential for career growth within an expanding team.
Defined career path and annual performance review & feedback process.
Cross-functional exposure to other areas within the organization.
Medical, Dental, Vision, and 401K are all offered from day one of employment.
152 hours of PTO and 8 paid holidays.
Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.