Vice President of Operations – Pharmaceutical Manufacturing / 503B

About the Role
We are seeking an experienced Vice President of Operations to lead operations for a growing, highly regulated organization in Dallas.

This is a senior executive leadership position with responsibility for pharmaceutical manufacturing, supply chain, inventory, distribution, facilities, capacity planning, and operational performance.

The ideal candidate is an established operations executive with 15+ years of progressive leadership experience and a strong background in pharmaceutical manufacturing, 503B outsourcing, specialty pharmacy, biotechnology, medical devices, or another FDA-regulated environment.

Candidates must have a strong understanding of cGMP, FDA requirements, quality systems, and regulated manufacturing operations, along with demonstrated success scaling operations and leading managers and directors.

Operations & Executive Leadership

• Lead day-to-day operational performance across manufacturing, supply chain, distribution, inventory, and facilities.
• Partner with executive leadership to establish and execute the organization's operational strategy.
• Develop operational KPIs, dashboards, goals, and performance metrics.
• Lead capacity planning and operational growth initiatives.
• Identify opportunities to improve productivity, efficiency, quality, and cost performance.
• Build scalable processes and infrastructure to support continued growth.

Pharmaceutical Manufacturing

• Provide executive oversight of pharmaceutical manufacturing and production operations.
• Ensure manufacturing operations meet quality, safety, productivity, and regulatory requirements.
• Drive continuous improvement and operational excellence initiatives.
• Establish and improve standardized operating procedures and processes.
• Support facility expansion, automation, equipment implementation, and new technology initiatives.
• Improve manufacturing throughput, capacity, and overall operational performance.

Supply Chain & Distribution

• Lead procurement, inventory management, warehousing, logistics, and distribution.
• Develop strategies to improve inventory performance and service levels.
• Ensure reliable availability of raw materials and finished products.
• Optimize fulfillment, logistics, and distribution operations.
• Develop supply chain strategies that support organizational growth and business continuity.

FDA / cGMP Compliance

• 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 corrective actions.
• Ensure operational processes support the organization's quality management system.
• Promote a culture of compliance, accountability, and continuous improvement.

Leadership & Talent Development

• Lead and develop directors, managers, and other operational leaders.
• Build high-performing, accountable operational teams.
• Establish performance expectations and leadership development plans.
• Develop succession plans and talent pipelines for critical operational positions.
• Mentor and develop future operational leaders.

Financial & Performance Management

• Develop and manage operational budgets.
• Monitor performance against financial and operational objectives.
• Identify cost-reduction and productivity opportunities.
• Ensure operational investments support long-term business growth while maintaining quality and compliance.