Supervisor, QC Data Review

Supervisor QC Data Review

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 MDjust minutes from BWI Airportfeatures 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 Supervisor QC Data Review is responsible for leading QC Data Reviewers and overseeing the review approval and management of data generated within QC. This position will lead the following areas: data review of QC assays oversight of routine release and stability testing documentation.

The Supervisor QC Data Review will report to the Manager of QC Cell Culture and Data Review.

The Role

• Supervise daytoday operations of the assigned QC Data Review function including workload planning prioritization and execution.
• Oversee performance of direct reports by monitoring quality of work productivity training status and adherence to cGMP and safety expectations.
• Perform and provide expert guidance on QC data review activities including verification of results calculations documentation accuracy and compliance with approved methods SOPs protocols and specifications.
• Lead troubleshooting and problemsolving efforts related to data review findings QC testing workflows and documentation issues.
• Ensure all QC data review activities comply with applicable ISO USP EU CFR cGMP and GLP requirements maintaining a constant state of audit readiness.
• Serve as lead support during regulatory and customer audits including preparation and presentation of data review records documentation and data integrity evidence.
• Author review and approve controlled documents such as SOPs forms templates and support nonroutine protocols validation plans and reports.
• Lead investigations change controls QCAs/CAPAs data trending and continuous improvement initiatives related to QC data review processes.
• Provide training and oversight to ensure staff are fully qualified in cGMP documentation practices safety requirements and new or revised data review procedures.
• Communicate effectively with QC leadership crossfunctional partners and management while maintaining flexibility to support offhour weekend or holiday testing timelines as required.
• Other duties as assigned by management.

The Candidate

• Bachelors degree in Microbiology Biology Chemistry or a related scientific discipline with a minimum of 6 years of experience in a cGMP QC/QA environment OR Masters degree in a related scientific discipline with a minimum of 4 years of cGMP QC/QA experience.
• 0 2 Progressive Leadership experience experience with Performance Management Goal Setting and Managing through Conflict.
• 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.
• Strong experience working in a cGMP Quality Control environment including review of analytical test methods validation documentation data packages and investigation of suspect or outoftrend results.
• Demonstrated use of quality tools such as SPC Root Cause Analysis FMEA 5 Whys HACCP and strong technical writing capabilities.
• Excellent organizational skills and attention to detail with strong proficiency in Microsoft Office and the ability to manage work successfully in a dynamic teamoriented environment.
• Strong verbal communication skills with internal teams and external clients or vendors and the ability to work an assigned shift.
• Physical Requirements: Ability to perform officebased and laboratory work including sitting at a desk/computer for documentation and data analysis; standing walking and sitting for extended periods in a laboratory environment; manual dexterity to safely handle laboratory instruments and equipment; occasional lifting of items up to 30 lbs; good vision and handeye coordination for detailed work; and consistent use of required personal protective equipment (PPE) such as lab coats gloves safety goggles and respiratory protection as applicable.

The anticipated salary range for this position in Maryland is $93280 to $128260 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 7000 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 . 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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California Job Seekers can find our California Job Applicant Notice HERE.