Director, Quality Engineering

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Industrial) or a related scientific discipline.
• Minimum of 10 years of progressive experience in a quality role within the pharmaceutical or biotech industry, with at least 5 years in a leadership role.
• Deep technical expertise in GMP-compliant manufacturing environments.
• Thorough understanding of global regulatory requirements and standards (FDA, EMA, MHRA, PMDA).
• Experience leading quality transformation initiatives that deliver regulatory confidence and operational excellence.
• Strong background in drug product manufacturing, preferably oral solid dosage forms.
• Ability to manage multiple projects and prioritize tasks in a dynamic environment.
• Excellent communication skills, both verbal and written, with ability to write concise technical documentation.
• 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 Skills & Background

• Master's degree.
• Experience with PowerBi, CoPilot Studio, Agentic AI.
• Experience in softgel technology.
• Experience in ISO 13485 and FDA 21 CFR Part 820.
• ASQ Certified Quality Engineer.
• Prior experience with BMRAM and Trackwise.
• Solid dosage or small molecule experience preferred; other dosage forms with relevant experience acceptable.

Why You Should Join Catalent

• 208 hours PTO plus 8 paid holidays.
• Medical, dental, and vision coverage options.
• Generous 401(k) match.
• Tuition reimbursement.

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 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.