Position SummaryWe have an opportunity for a Director, Quality Engineering to join our team and lead strategic GMP initiatives in a fast-paced, highly regulated pharmaceutical CDMO environment. This role ensures product quality, patient safety, and regulatory compliance by embedding a proactive, risk-based quality mindset across the site. You will partner with cross-functional teams and lead a group of quality engineers and validation specialists to support process validation, equipment qualification, and data integrity. This is a key leadership position that drives quality oversight throughout the product lifecycle while fostering a high-performance culture.
Shift: Monday - Friday 8:00AM - 5:00PM
Location: St. Petersburg, FL
100% Onsite
The Role- Lead the development and execution of GMP quality engineering strategies aligned with regulatory expectations and business objectives.
- Provide quality engineering oversight for manufacturing activities, technology transfer, scale-up, equipment qualification, cleaning validation, process validation, and commercial production to ensure GMP compliance.
- Apply Quality Risk Management principles in quality engineering activities.
- Oversee enhancement and maintenance of the site's change control system, including validation master planning, lifecycle validation approaches, and periodic review.
- Support deviation investigations and corrective and preventive actions related to equipment, process, and automation.
- Strengthen data integrity controls in electronic systems and ensure compliance for computerized systems validation and 21 CFR Part 11 and Annex 11 principles.
- Develop and implement risk-based monitoring and metrics to assess change control system performance and effectiveness.
- Drive digitalization and automation initiatives related to quality engineering processes and metrics.
- Lead and mentor a team of quality engineers and validation specialists; build capabilities through training and coaching.
- Drive continuous improvement initiatives using Lean, Six Sigma, and root cause analysis to improve product quality and operational efficiency.
The CandidateMinimum Requirements- 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.
