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Sr. Manager, Quality

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 Sr. Manager, Quality is responsible for providing end-to-end Quality Assurance (QA) and Quality Control (QC) oversight for the BWI2 plasmid DNA (pDNA) manufacturing facility. This role ensures that all operations meet GMP requirements, internal quality standards, and regulatory expectations (FDA, EMA, ICH, and applicable pharmacopeias).

As the facility progresses from early build-out and commissioning to full GMP readiness, the Sr. Manager, Quality will serve as a key quality decision-maker, establishing phase-appropriate quality systems, building quality capabilities, and ensuring inspection readiness.

This is a hands-on leadership role requiring strong technical knowledge in plasmid manufacturing, raw material controls, aseptic and non-aseptic operations, and analytical testing of pDNA. The position reports directly to the Vice President of Quality Cell and Gene Therapy.

The Sr. Manager, Quality will report to the Vice President, Quality.

The Role

• Lead GMP readiness and quality oversight during facility design, commissioning, qualification, and startup, including URS review, change control, and validation documentation.
• Develop, implement, and maintain GMP-compliant Quality Systems, including deviations, CAPA, change control, batch release, document management, and training.
• Ensure phase-appropriate quality controls as operations transition from engineering and clinical setup into full GMP manufacturing.
• Serve as QA lead for plasmid manufacturing operations, providing oversight of batch execution, deviations, investigations, risk assessments, CAPAs, and lot disposition decisions.
• Review and approve master batch records, SOPs, validation protocols/reports, and all quality-impacting documentation.
• Provide on-the-floor QA support during critical manufacturing operations including fermentation, harvest, lysis, purification, and sterile filtration, as applicable.
• Oversee Quality Control activities, ensuring GMP-compliant laboratories, methods, instrumentation, analysts, and testing programs for plasmid DNA and raw materials.
• Support QC method transfer, qualification, validation, stability programs, and OOS/OOT investigations.
• Lead inspection readiness activities and support regulatory inspections and client audits, including preparation, execution, responses, and remediation.
• Build, lead, and develop a high-performing QA/QC team through coaching, training, workload prioritization, and career development while fostering a strong Quality Culture.
• Partner cross-functionally with Manufacturing, MS&T, Facilities/Engineering, Project Management, Supply Chain, Regulatory, and other stakeholders to resolve quality issues and drive alignment.
• Drive continuous improvement through quality metrics/KPIs, root cause analysis, quality risk management (ICH Q9), and proactive evaluation of regulatory and industry standards.
• 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 experience, within biologics, biopharmaceuticals, or a similarly regulated industry OR Bachelor's degree in a Scientific, Engineering, or Biotech discipline with 8+ years of Quality Assurance/Quality Control experience, within biologics, biopharmaceuticals, or a similarly regulated industry.
• 5+ years of progressive leadership and direct management experience.
• Demonstrableleadershipexperience at Catalent (including but not limited to participation in Catalent-sponsoredleadershipprograms such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• Proficient with electronic quality systems and reporting tools, including Microsoft Office; experience with LIMS, MasterControl, and TrackWise preferred.
• Strong analytical, troubleshooting, and decision-making skills with a creative, solutions-oriented approach in a GMP environment.
• Solid understanding of biologics manufacturing processes (required), including fermentation, purification, contamination control, and segregation requirements; plasmid DNA manufacturing experience preferred, with the ability to quickly learn novel processes supporting new clients.
• Ability to work effectively both independently and in a team-based environment under minimal supervision while meeting aggressive timelines.
• Proven ability to deliver results in a fast-paced, client-driven GMP environment, with flexibility to support off-shift coverage, on-call escalation, and periodic weekend work as business needs require.
• 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 $165,000 - $185,000 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:

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