VP, Technical Services Operations, Compounding

Remote Full-time
Job Description: • 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
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