Quality Manager Jobs

About The Position

Requirements

• Bachelor’s degree in science or a related field, such as Chemistry, Microbiology, or Biology.
• At least five years of pharmaceutical and dietary supplement quality experience.
• At least seven years of related experience, including three to four years in a supervisory or management role.
• Experience with current Good Manufacturing Practice compliance and in a quality role within pharmaceutical or dietary supplement manufacturing.
• Ability to work effectively under pressure to meet deadlines.
• Ability to sit, stand, and walk regularly and occasionally lift up to 15 pounds; lifting more than 44.09 pounds requires assistance.
• Ability to access the manufacturing floor and office staff and use required office equipment.
• Ability to read written documents and frequently use a computer monitor.
• Demonstrable Catalent leadership experience, including participation in programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW, may be considered in place of external experience.

Nice To Haves

• Experience writing investigations, including root cause analyses and annual product review reports.
• Familiarity with 21 CFR 111, 21 CFR 117, 21 CFR 211, GFSI, HACCP, Preventive Controls Qualified Individual, SQF, NSF, and UL certifications.
• Experience with electronic systems such as JDE, TrackWise, Electronic Document Management System, Learning Management System, Quality Management System, Veeva, Compliance Wire, and Stability Programs.
• Experience communicating with FDA inspectors or other regulatory agents and handling FDA 483 responses.
• Experience using artificial intelligence tools to improve quality systems.

Responsibilities

• Oversee Quality and Compliance functions related to dietary supplement manufacturing at the Greendale site.
• Lead Quality Assurance Supervisors and Specialists responsible for operational quality, product sampling, testing, and product release.
• Review and approve manufacturing and packaging change controls, product formulations, label changes, deviations, corrective and preventive action plans, and customer complaints.
• Ensure compliance with FDA, NSF, and SQF requirements and participate in internal and external audits.
• Develop and maintain quality and compliance policies, procedures, and guidelines.
• Identify and mitigate product-quality risks and oversee root cause analyses and corrective actions.
• Lead the Food Safety Team and ensure compliance with 21 CFR 110 and 117, HACCP Food Safety, and Food Defense Plans.
• Monitor the sanitary state of the facility and equipment to support cross-contamination control.
• Work with Operations to assess sanitation program effectiveness and ensure compliance with food safety guidelines.
• Maintain communication with Customer Service to address quality issues affecting product release.
• Oversee training programs on quality standards and compliance requirements.
• Establish and track key performance indicators for quality and compliance.
• Collaborate with Product Development, Technical Operations, and Supply Chain to integrate quality into production processes.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Communicate with regulatory agencies, external auditors, and internal stakeholders about quality and compliance matters.
• Oversee investigations, environmental monitoring, and critical control point incidents that affect product release.
• Support site management in enforcing current Good Manufacturing Practices and mentor staff in compliance.
• Facilitate internal assessments, compliance meetings, and training sessions.

Benefits

• Competitive paid time off and eight paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Site-based employee engagement activities.
• Employee Resource Groups focused on diversity and inclusion.
• Environmentally friendly community engagement green initiatives.
• Defined career path and annual performance review process with potential for career growth.
• WellHub program promoting physical and mental wellness.
• Perkspot discounts from more than 900 merchants.