Quality Program Manager

Position Summary

The Quality Program Manager is responsible for being the liaison between the client and Catalent and the primary Quality advocate to facilitate project completion. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a Quality relationship. The Quality Program Manager will ensure adherence to schedules and proactively communicate client deliverables to each department and ensure milestones and targets are met or exceeded. Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels within the organization.

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

• Work closely with Catalent Philadelphia site in order to obtain necessary information for clients to support their projects and requests.

• Host customer audits and visits; Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions.

• Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective; Attend Distribution kick-off meetings to assist Distribution staff with Quality alignment; Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered.

• Act as the primary contact person for client-specific questions and liaison between client and Catalent staff; Act as the primary contact with clients if there are questions on documentation, process questions, issues, etc.

• Prepare slide decks/metrics on “Quality-Owned” information; Prepare GMP Storage Statements upon request.

• Provide planning and scheduling with Quality and ensure timeline adherence; help prioritize for different departments and track progress.

• Work closely with global quality network team to complete client quality agreement review and approval; Provide global quality network team support for global impact assessments.

• Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff.

• Report investigation status to Quality management and relevant site management; Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested.

• Review and ensure necessary information is available for quarantine shipments to and from Catalent Philadelphia.

The Candidate

• Minimum of a High School Diploma with 5 years of experience in the Pharmaceutical or closely related field. BA/BS Degree strongly preferred.
• Must have effective communication skills that includes both oral and written communications as well as the ability to interpret client documents, Catalent SOPs, and regulatory requirements.
• Auditing experience is desirable. Must demonstrate organizational skills, be able to interact with personnel at all levels from a variety of disciplines and be knowledgeable in cGMPs.
• Superior customer service orientation with strong follow-up skills and attention to detail.
• Advanced PC skills, knowledge of company specific software packages.
• Must be a self-starter, be able to work independently, ability to communicate in large groups as well as small, and have the ability to multi-task under strict deadlines.

Why you should join Catalent

• Medical, Dental, Vision and 401K are all offered from day one of employment

• 19 days of paid time off annually

• Potential for career growth within an expanding team

• Defined career path and annual performance review and feedback process

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.

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 spam@catalent.com for us to investigate with local authorities.