The Manager, Quality Systems Audit is responsible for the management and oversight of the core quality systems related to Supplier Quality Management, including supplier qualification, quality agreements, audits, complaints, CAPA tracking, supplier change and alert notifications and risk management.  This role is also responsible for compiling, trending and reporting key Supplier Quality metrics for Senior Leadership review. This role may also engage on all aspects of raw material management including material qualification, specifications, reduced testing programs and warehousing practices. This role manages the Supplier Quality team which supports all Catalent Gene Therapy sites.

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:

Manages the QA staff supporting Investigation/Deviation/ CAPA Management, Change Control, Risk Management, Quality Metric Tracking responsibilities.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.Responsible for and administers Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolutionResponsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitmentsPerform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actionsResponsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controlsResponsible for and administers the Risk management system and track completion of risk assessments

The candidate:

Masters’ degree in a Scientific, Engineering or Biotech field with 6 - 8 years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentationBachelor’s degree in a Scientific, Engineering or Biotech field with 8 - 10 years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation.2 – 4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict. ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirableHave the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasksDemonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820

The anticipated salary range for this position in Maryland is $118,720-163,240 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 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity 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.

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