Catalent · 2 months ago
Associate Director Quality Assurance
Philadelphia, PA
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expCatalent, Inc. is a leading global contract development and manufacturing organization dedicated to developing, manufacturing, and supplying products that enhance people's lives. The Associate Director, Quality Assurance will provide leadership and support at the Philadelphia site, ensuring quality assurance for clinical and commercial manufacturing operations, while adhering to cGMP guidelines and corporate quality policies.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
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
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
WellHub - program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
2026-01-16
Company data provided by crunchbase