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.
- 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.
- 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.
