Vice President of Operations 503B Pharmacy

Vice President of Operations 503B Pharmacy About the Role

We are seeking an experienced Vice President of Operations to join our executive leadership team and lead operational strategy and performance for a highly regulated pharmaceutical organization.

This is a senior pharmaceutical operations leadership role overseeing manufacturing, supply chain, distribution, inventory, facilities, and operational planning.

Candidates MUST have significant operations leadership experience within a highly regulated industry, with direct experience in pharmaceutical manufacturing, specialty pharmacy, biotechnology, medical devices, or another FDA-regulated environment. Experience with 503B outsourcing facilities is highly valued.

Candidates without experience in an FDA-regulated industry or comparable regulated healthcare/pharmaceutical environment will not be considered.

• Develop and execute operational strategy in partnership with executive leadership.
• Establish and manage operational KPIs, performance metrics, dashboards, and goals.
• Lead long-term capacity planning and operational growth initiatives.
• Oversee pharmaceutical manufacturing and production operations
  .
• Drive improvements in productivity, efficiency, throughput, quality, and operating costs.
• Lead procurement, inventory management, warehousing, logistics, and distribution.
• Ensure reliable availability of raw materials and finished products.
• Support facility expansions, automation projects, technology implementations, and growth initiatives.
• Partner with Quality and Regulatory leadership to maintain continuous inspection readiness.
• Ensure operations comply with FDA regulations, cGMP requirements, USP standards, and applicable state regulations
  .
• Support FDA inspections, regulatory audits, internal audits, and compliance initiatives.
• Develop, coach, and retain directors, managers, and other operational leaders.
• Build a culture of accountability, quality, collaboration, and continuous improvement.
• Develop succession plans and leadership talent pipelines.
• Develop and manage operational budgets and monitor performance against financial objectives.

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Supply Chain, Business, or a related field
  .
• 15+ years of progressive operations leadership experience.
• 7+ years leading managers, directors, or other senior operational leaders.
• REQUIRED:
  Significant operations leadership experience in one or more of the following:
• Pharmaceutical manufacturing
• Specialty pharmacy
• 503B outsourcing facilities
• Biotechnology
• Another FDA-regulated industry
• Strong understanding of FDA regulations, cGMP requirements, and quality systems
  .
• Demonstrated success scaling operations in a growth-oriented environment.
• Experience leading large, cross-functional teams.
• Proven experience managing operational budgets and financial performance.
• Strong strategic planning, operational improvement, and executive leadership skills.

Direct 503B outsourcing facility experience is highly preferred. Candidates with experience operating pharmaceutical manufacturing or compounding operations under FDA oversight, including responsibility for production, quality, supply chain, facilities, and regulatory readiness, are encouraged to apply.

• MBA or advanced scientific degree.
• Direct 503B outsourcing facility experience.
• Pharmaceutical manufacturing leadership experience.
• Lean Six Sigma Black Belt or comparable operational excellence certification.
• Experience with facility expansions, automation, or startup operations.
• Experience preparing organizations for FDA inspections
  .
• Experience implementing scalable processes and operational systems during periods of rapid growth.

• Increased operational efficiency, productivity, and throughput.
• Improved inventory and supply chain performance.
• Strong regulatory compliance and inspection readiness.
• Scalable processes supporting continued organizational growth.
• Effective operational KPI dashboards and reporting.
• Strong leadership succession and talent pipelines.
• Measurable productivity and cost improvements.
• A culture of accountability, quality, and continuous improvement.

Salary: $275,000–$295,000 per year
Location: Dallas, TX 75226
Job Type: Full-Time
Seniority Level: Executive / Vice President

This position is specifically seeking an executive operations leader with experience in pharmaceutical manufacturing, specialty pharmacy, biotechnology, medical devices, 503B outsourcing, or another FDA-regulated environment.

General operations leadership experience outside of regulated industries will not meet the core experience requirement.

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