Associate Director Quality Assurance

This is a full-time salaried position based onsite at our Philadelphia, PA office.

About the Role

The Associate Director, Quality Assurance is accountable for the group providing Quality Assurance support to clinical and commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, and improving activities related to process and support to business demands. Our Philadelphia facility is our North American Center of Excellence for clinical supply packaging.

• Quality liaison for clients and internal customers; expected to become the owner or escalation point for client requests/issues
• Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus
• Participate in Regulatory Inspections and Customer Audits
• Participate in site and customer meetings/communications and be directly involved in critical projects/issues
• Establish goals and monitor performance through monthly, quarterly, and annual summaries and metrics
• Present summary data to site management on a regularly scheduled basis
• Provide QA technical recommendations based on trend analysis to eliminate future problems
• Participate in project meetings to provide input with respect to compliance to cGMP requirements
• Other duties as assigned

Requirements

• Bachelor’s degree in a scientific discipline (chemistry, biochemistry, biology, microbiology, or chemical engineering)
• Minimum of 10 years’ relevant experience in the pharmaceutical industry
• Minimum four years of leadership/management experience with demonstrated ability to set vision and direction for a team, including setting expectations and motivating for results to achieve corporate, site, and departmental objectives
• Working knowledge of cGMP regulations; experience in multiple regions (e.g., EU, ANVISA, FDA) preferred
• Experience working with customers—contract manufacturing experience preferred
• Prior experience working with quality control or GMP manufacturing/packaging preferred
• Prior experience working directly with regulatory agencies and handling inspections preferred
• Demonstrable leadership experience at Catalent (including participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
• Individual may be required to sit, stand, walk regularly, and occasionally lift 0-15 pounds

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO + 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition reimbursement
• WellHub – program to promote overall physical wellness
• Perkspot – offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories