Manager, Quality Systems

Manager, Quality Systems

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.

Greendale is one of Catalent’s gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers.  Simply put – we make healthy gummies. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Manager, Quality Systems is responsible for the creation and maintenance of the Quality System documentation. Communicate any deviations to management. The Manager, Quality Systems will assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.

The Role

• Subject Matter Expert (SME) for SQF, FSMA/HACCP and 21 CFR 111 Standards and implementation.

• SQF Practitioner and FSMA PCQI lead for the site.

• Responsible for validation of the Food Safety Preventative Controls.

• Manage and report on the Environmental Monitoring program execution, performance and corrective actions.

• Manage, trend and report Customer Complaints and lead investigations for completion of Customer CARs.

• Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper formatting, numbering and organization of all related documents: MMRs, specifications, BPRs, Food Safety and Quality Plans and any other documents as required.

• Manage the internal plant routing and approval process for new documents and process deviations.

• Lead the internal audit program by managing the internal audit schedule, training of internal auditors, performing internal audits and inspections and documenting all areas of non-conformance to support continuous improvement efforts and ensure corrective actions are implemented to eliminate them.

• Responsible to completion and response to all Customer related Non-conformance reports.

• Work with Production and Packaging Managers, Supervisors, and R&D to maintain and update records and documentation

• Other duties as assigned

The Candidate

• Bachelor's degree in Food Science, Biology, Chemistry, or other related major required.

• 5+ years of experience in a GMP facility in a managerial role required.

• SQF Practitioner with implementation experience required.

• FSMA Preventative Control and Qualified Individual (PCQI) and HACCP trained within the last 3 to 5 years with experience implementing and validating Food Safety programs required.

• Experience implementing cGMP and 21 CFR 111 Standards is a plus.

• Experience implementing and managing Environmental Monitoring Programs.

• Knowledge of NLEA labeling requirements is a plus.

• Supplier Auditor certification preferred

• For business and safety reasons, must be able to communicate effectively verbally and in written English.

• Ability to communicate with all line level positions and management

• Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers.

• The employee must be able to lift and/or move up to 25 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or
  crawl, and talk or hear. The employee is required to sit, climb or balance and taste or smell.

Why you should join Catalent

• Diverse, inclusive culture

• Competitive salary

• 401(k) retirement savings plan with company match

• Educational assistance/reimbursement

• 152 hours of paid time off + 8 paid holidays

• Medical, dental, and vision insurance

• Life insurance

• Wellness programs

• Flexible spending account

• Employee discount programs

• Robust employee referral program