VP, Technical Services Operations, Compounding

Role Overview

• 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
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats