VP, Technical Services Operations Compounding

Hims & Hers

9d

About The Position

As VP, Technical Services Operations Compounding, you will be the senior technical authority responsible for end-to-end technical governance across all sterile and non-sterile compounding operations. This executive-level role drives operational discipline, consistency, and compliance to support the organization's growth and regulatory readiness.
You will build and lead a cross functional matrix team responsible for investigating deviations within the 503A and 503B compounding area, identifying root causes, and driving effective corrective and preventive actions (CAPAs). This role ensures compliance with all appropriate standards and regulations that supports continuous improvement, and strengthens operational discipline through data-driven problem-solving.
The VP ensures that products are manufactured consistently, reliably, and compliantly across all sites while building scalable technical systems to support portfolio growth, capacity expansion, and regulatory 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

Nice To Haves

• Head-of-Function experience in pharma, CDMO, or 503A/503B compounding.
• Lean Six Sigma certification or demonstrated operational excellence leadership.
• Experience scaling technical systems in high-growth or transformation environments.
• Strong technical writing and regulatory response authorship experience.
• Strong analytical, organizational, and interpersonal skills.
• Experience working with Regulatory authorities.

Responsibilities

• Investigations, Deviations, and CAPA Leadership: 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). The role establishes and monitors metrics for deviation recurrence and CAPA effectiveness.
• Validation Strategy and Execution: Owning the global validation strategy for process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation. This includes aligning the validation lifecycle with FDA, USP (<795>, <797>, <800>), and ICH Q8–Q10 expectations as appropriate.
• Product Performance, Trending, and Reliability: Establishing systems for routine statistical trending of critical quality attributes (CQAs), process capability, and yield. The VP translates this data into technical recommendations to improve product robustness and reliability.
• Technology Transfer and Site-to-Site Standardization: Leading and approving all technology and product transfers, ensuring complete process understanding. This also involves driving harmonization of processes, equipment platforms, SOPs, and batch records across all sterile and non-sterile operations.
• Technology Strategy and Roadmap Develop and govern the multi-year technology roadmap for compounding operations, covering equipment, automation, digital systems, and facility upgrades. Collaborate with Engineering, Quality, R&D, Digital, Finance, and Operations to strategically align technology investments with business goals. Lead capital planning, vendor selection, and provide ROI justification for all manufacturing technologies.
• Operational Excellence and Continuous Improvement: Deploying Lean Six Sigma, Kaizen, and other continuous improvement methodologies across compounding and R&D operations, defining KPIs, and sponsoring improvement projects that deliver measurable quality and cost benefits.
• Regulatory Engagement and Audit Readiness: 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.
• Cross-Functional Leadership, operating as a matrix leader across teams like Compounding, Quality, Engineering, R&D, and Regulatory Affairs to resolve technical and organizational trade-offs.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 1-10 employees