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Associate Director, Quality Assurance

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.

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.

The Role:

+ 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

The Candidate:

+ 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

Why You Should Join Catalent:

+ 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

+ 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.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .