Associate Director Quality Assurance

Catalent•Philadelphia, PA

22h•Onsite

About The Position

Associate Director, Quality Assurance Position Summary: This is a full-time salaried position, onsite out of Philadelphia, PA. The Associate Director, Quality Assurance is responsible for providing leadership and support within Catalent’s Philadelphia site. The Associate Director, QA is accountable for the group providing Quality Assurance support to clinical & commercial manufacturing operations within the facility. This includes but is not limited to shop floor quality, batch record review, deviation management, customer interface, improving activities related to process and support to business demands. The Associate Director, Quality Assurance is responsible for directing the QA teams for the manufacturing floor/area, batch record review/release activities, commercial customer support. The position will have 4 to 5 direct reports and a total of 30 to 40 indirect reports. Will work directly with QA managers/supervisors and operations to improve processes and procedures. Responsible for ensuring the site is following cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Clinical Supply Services quality standards across the area of focus. Position requires partnership with other functional areas (e.g. Product Development, Project Management, Operations, Customer Service, Packaging etc.) to ensure continued compliance for the area/site. Will provide directional support and as required, hands-on, leadership to drive actions and enhancements to the QMS. Will be a key decision maker and point of escalation for operations, customer and internal concerns/issues. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Requirements

Bachelor’s degree in scientific discipline, chemistry, biochemistry, biology, microbiology, or chemical engineering, required
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 cGMPs regulations, required; prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
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
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Responsibilities

Quality liaison for clients and internal customers; is 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, etc
Participate in site and customer meetings/communications and be directly involved in critical projects/issues
Establishes goals and monitors 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
Participates in project meetings to provide input with respect to compliance to cGMP requirements
Other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
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
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
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