Associate Director Quality Assurance

Catalent; Philadelphia (Philadelphia County); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

152 hours PTO + 8 paid holidays

Medical, dental and vision benefits

Tuition Reimbursement

WellHub wellness program

Perkspot discounts

Job summary

Catalent is seeking an Associate Director, Quality Assurance to lead QA support for clinical & commercial manufacturing at our Philadelphia facility. The role focuses on shop floor quality, batch record review, deviation management, and client interface to meet business needs.

The candidate will oversee QA activities, participate in regulatory inspections and customer audits, and drive metrics, performance reviews, and continuous improvement initiatives across the site.

Qualifications

• Bachelor’s degree in scientific discipline is required.
• Minimum 10 years of relevant pharmaceutical industry experience.
• Leadership experience with ability to set vision and motivate a team.
• Working knowledge of cGMP regulations and regulatory inspections.
• Experience interacting with customers and contract manufacturing groups.
• Experience with quality control or GMP manufacturing/packaging is preferred.

Responsibilities

• Quality liaison for clients and internal customers; become owner/escalation point for client requests.
• Maintain and nurture client partnerships to ensure alignment and consensus.
• Participate in Regulatory Inspections and Customer Audits, etc.
• Participate in site and customer meetings and critical projects.
• Establish goals and monitor performance with monthly, quarterly, and annual metrics.
• Present summary data to site management on a regular basis.
• Provide QA recommendations based on trend analysis to prevent issues.
• Contribute to compliance with cGMP requirements in projects.

Skills

Leadership

Quality Assurance

Client liaison

Regulatory audits

cGMP knowledge

Cross-functional

Education

Bachelor’s degree in science

Job description

Associate Director, Quality Assurance

Position Summary:

• This is a full-time salaried position
• Based onsite out of Philadelphia, PA office

T he Associate Director, Quality Assurance 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.

Our Philadelphia facility is our North American Center of Excellence for clinical supply packaging.

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
• 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.

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 [e-mail].