Manager, QC Program Management

The Manager, QC Client Services is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client’s analytical implementation.  Manage the OTL for analytical method implementation and support SMPs and Batch records implementation review.

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The role:

• Be the face of Catalent Quality Control during Client onboarding
• Manage the day-to-day method establishment.
• Attend client meetings to establish testing and stability protocols
• Ensure completion of project team assigned QC related activities.
• Coordinate internal testing with Quality Control group
• Coordinate product and raw material testing with external testing laboratories
• Coordinate with the stability group and clients to establish stability studies.
• Review and approve client sampling plans.
• Review and approve batch records. Ensure sample testing schedule is accurate.
• Develop and maintain QC client activities tracker.
• Communicate manufacturing and testing schedules to the Quality Control group.
• Effectively communicates with clients on QC related items/results.

The candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 6 – 8 years’ experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review.
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 8 - 10 years’ experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review. 
• Strong communication skills.
• Proficient in Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines.
• Demonstrable 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.
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Exposure to Lean Operational Excellence highly desirable.

The anticipated salary range for this position in Maryland is $118,720 $163,240 plus an annual bonus. 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

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 [email protected]. 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:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

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