Supervisor, Technical Investigations

Catalent•Philadelphia, PA

12d•Onsite

About The Position

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.

Requirements

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

Responsibilities

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.

Benefits

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.