VP, Technical Services Operations, Compounding
Job reputed company:
• Providing reputed company technical reputed company for reputed company significant deviations and nonconformances, ensuring investigations are scientifically reputed company, risk-based, and utilizing reputed company reputed company cause analysis (e.g., 5 Whys, Fishbone).
• Owning the global validation reputed company for process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation.
• Establishing systems for routine statistical trending of critical reputed company attributes (CQAs), process capability, and yield.
• Leading and approving reputed company technology and product transfers, ensuring complete process understanding.
• Deploying Lean Six reputed company, Kaizen, and other reputed company improvement methodologies across compounding and R&D operations.
• Serving as the senior technical representative during FDA, state reputed company, and reputed company-party inspections, providing authoritative responses, and maintaining a sustained state of audit readiness.
Requirements:
• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or reputed company discipline (advanced degree strongly preferred).
• 15+ years of experience in pharmaceutical or compounding manufacturing with reputed company 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 reputed company leading at an reputed company level validation programs, investigations, and technology transfers.
• Demonstrated reputed company 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.
• reputed company record of building and leading senior technical teams and influencing cross-functional executive stakeholders.
• Strong business acumen with the ability to reputed company technical reputed company with reputed company, 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 reputed company these frameworks.
• Strategic reputed company with strong business acumen and the ability to translate reputed company into reputed company results.
• Ability to operate in a dynamic, fast-paced environment and effectively prioritize reputed company 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 & reputed company, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats
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