Supervisor, Technical Investigations

Investigations Supervisor Position Summary: Work Schedule: M-F 1st shift 100% on-site This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. Catalent Pharma Solutions in Philadelphia, PA is hiring an Investigations Supervisor. The Investigations Supervisor provides oversight and leadership to the team responsible for conducting and authoring deviation and complaint investigations associated with the packaging, storage and distribution of clinical and commercial drug products. This includes managing individual contributors to ensure timely and quality execution of investigations, and daily collaboration across departments to ensure proper investigations are completed with identification of effective CAPA. The Role: Accountable for timely and effective completion of deviation and complaint investigations conducted by the Investigations team Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems. Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes. Develops and provides training to support consistent and effective execution of the Investigation and CAPA Management Systems Serves as local TrackWise® Subject Matter Expert performing administrative functions Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations. Responsible for maintaining sufficient understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Systems Manager. Maintains data integrity and ensure compliance with company SOP’s, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines. Provides technical assistance and training for personnel. Files and maintains controlled documents. Other duties as assigned. The Candidate: Bachelor’s Degree required, preferably in Life Science or Business Minimum of 2 - 5 years of CAPA, investigations, or manufacturing quality assurance experience Minimum of 5 years manufacturing/technical experience in a regulated GMP environment; pharmaceutical industry preferred Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories 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. 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. 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.