Providing direct technical oversight for all significant deviations and nonconformances, ensuring investigations are scientifically sound, risk-based, and utilizing structured root cause analysis (e.g., 5 Whys, Fishbone).
Owning the global validation strategy for process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation.
Establishing systems for routine statistical trending of critical quality attributes (CQAs), process capability, and yield.
Leading and approving all technology and product transfers, ensuring complete process understanding.
Deploying Lean Six Sigma, Kaizen, and other continuous improvement methodologies across compounding and R&D operations.
Serving as the senior technical representative during FDA, state board, and third-party inspections, providing authoritative responses, and maintaining a sustained state of audit readiness.
Requirements
Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related discipline (advanced degree strongly preferred).
15+ years of experience in pharmaceutical or compounding manufacturing with progressive technical leadership responsibility.
Deep expertise in technical operations whether in Pharmaceutical or 503A and/or 503B operations, sterile and non-sterile processing, and regulatory expectations.
Demonstrated success leading at an enterprise level validation programs, investigations, and technology transfers.
Demonstrated track record of building, leading, and managing technical teams.
Deep expertise in sterile and non-sterile compounding, validation lifecycle management, investigations, and regulatory compliance.
Proven experience interacting with FDA and regulatory inspections as a senior technical authority.
Track record of building and leading senior technical teams and influencing cross-functional executive stakeholders.
Strong business acumen with the ability to align technical strategy with growth, capital planning, and corporate objectives.
Strong executive communication, decision-making, and change leadership skills.
Deep understanding of regulatory and operational environments, and experience working cross functionally within these frameworks.
Strategic mindset with strong business acumen and the ability to translate strategy into tangible results.
Ability to operate in a dynamic, fast-paced environment and effectively prioritize complex initiatives.
Organized, methodical, strong steering, analytical and problem-solving skills
Ability to be flexible and adaptable to changing priorities and environments.
Benefits
Competitive salary & equity compensation for full-time roles
Unlimited PTO, company holidays, and quarterly mental health days
Comprehensive health benefits including medical, dental & vision, and parental leave