Supervisor, Client QA

The Supervisor, Client QA is responsible for providing QA support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product.  Overseeing the Client Support team and serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The role:

• Supervision of Client Support processes and personnel.
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines 
• Build effective teams that apply their diverse skills and perspectives to achieve common goals.
• Drive engagement and create a culture where employees are motivated to do their best.
• Oversee daily activity for the group to ensure quality results Performance management for direct reports.
• Provides dedicated QA support to client projects and client interactions & meetings.  Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product
• Involved from inception of a client’s project until project closure. Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.
• Responsible for tracking, documenting and presenting Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch)
• Oversee QA Support with clients during initial and subsequent manufacturing campaigns
• Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs)
• Performs risk analysis and mitigation, using available tools such as FMEA, when needed.

The candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 4 – 6 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 6 - 8 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• 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.

The anticipated salary range for this position in Maryland is $93,280 – $128,260 plus an annual bonus target. 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:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your car