Director, Quality Engineering

Catalent•Saint Petersburg, FL

10d•Onsite

About The Position

We 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.

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.

Nice To Haves

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.

Responsibilities

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.