Job Information
Catalent Pharma Solutions Director, Quality in Philadelphia, Pennsylvania
Director, Quality
Position Summary
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.
Our Philadelphia location is the largest in the Catalent Clinical Supply Services network, providing comprehensive clinical supply services for our customers, including clinical supply management and comparator sourcing, primary and secondary packaging, and storage and distribution. We also offer a variety of specialized services such as demand-led supply, direct-to-patient services (which includes an on-site pharmacy within our facility), and small-scale commercial packaging for advanced therapies.
The Director of Quality is responsible for providing leadership and Quality Management support within the Clinical supply site. This individual will have responsibility for Quality aspects related to Quality Management Systems, Finished Product Batch Release, Change Control, and Customer relations.
The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and Australian agencies and other international and/or local health authorities.
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
Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance.
Manages responsibilities include professional development, performance appraisals, and employee counselling for direct reports. Assigns work and reviews workload for all direct reports. Supervises staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks to commensurate with skill level.
Recommends courses of action on all management/human resources’ matters, including salary administration, transfers, hiring, terminations, and position description preparation.
Promotes, implements, and maintains quality initiatives of processes and programs to assess compliance with regulations, Global and Site SOPs, and client requirements.
Provides to the Operational CSS and Quality organization consultation, and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials, as applicable.
Writes and approves Quality unit SOPs and Forms, as needed. Approves Operational CSS SOPs and Forms. Supports harmonization of worldwide Quality operating procedures as needed.
Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle.
Assists with Client Audit and Regulatory Agency inspections and -provides leadership for the investigations, root cause analysis, and CAPAs associated with Deviations, Non-conformances, Complaints, Client Audits, and Internal Audit Reports.
Provides direction in identification and implementation of quality improvement programs.
Other duties as assigned.
The Candidate
BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience.
10+ years of Scientific or Quality Assurance in clinical trials packaging, in addition of commercial manufacturing and packaging; Clear understanding of cGMPs including clinical trials.
Communicates clearly with direct reports, internal and external clients, both verbal and written.
Demonstrates flexibility in organizing work and priorities. Good organizational skills relating to management of associates daily activities.
Good problem-solving skills and decision-making skills to identify and solve work related issues.
Good change management skills and strategic thinking
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
Why You Should Join Catalent
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
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 (https://careers.catalent.com/us/en) 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.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .