Vice President of Operations – Pharmaceutical Manufacturing / 503B

Location: Dallas, TX 75226
Salary: $275,000 – $295,000 per year
Job Type: Full-Time
Industry: Pharmaceutical / Biotech / Medical Device / FDA-Regulated Operations

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.

Compensation

$275,000 – $295,000 annually

Key Responsibilities

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.

Required Qualifications

• 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.

• Experience in pharmaceutical manufacturing, 503B outsourcing, specialty pharmacy, biotechnology, medical devices, or another FDA-regulated industry.

• Strong knowledge of cGMP regulations and pharmaceutical quality systems.

• Demonstrated experience scaling operations in a growing organization.

• Experience leading large, cross-functional operational teams.

• Proven experience managing budgets, KPIs, productivity, and operational performance.

• Strong executive communication, strategic planning, and decision-making skills.

Preferred Qualifications

• MBA or advanced scientific/technical degree.

• Direct experience with 503B outsourcing facilities.

• Pharmaceutical manufacturing leadership experience.

• Lean Six Sigma Black Belt or comparable operational excellence certification.

• Experience with facility expansions, automation, technology implementation, or startup operations.

• Experience preparing organizations for FDA inspections.

• Experience building operational infrastructure during periods of rapid growth.

What We're Looking For

The strongest candidates will have a track record of leading complex operations in a highly regulated environment and will be comfortable operating at both the strategic and tactical levels.

This opportunity is particularly well suited for a current or former:

• Vice President of Operations

• SVP of Operations

• Chief Operating Officer

• Senior Director of Operations

• Director of Operations ready for VP-level responsibility

• Pharmaceutical Manufacturing Executive

• 503B Operations Executive

• Pharmaceutical Operations Leader

• Biotech Operations Executive

• Medical Device Operations Executive

Candidates should have demonstrated experience with regulated manufacturing, cGMP compliance, operational scaling, supply chain, production, quality systems, and executive-level team leadership.

Why Apply?

• $275,000 – $295,000 base salary

• Executive leadership position

• Significant operational ownership and decision-making authority

• Opportunity to lead and scale a growing organization

• Direct impact across manufacturing, supply chain, distribution, and facilities

• Opportunity to build high-performing operational leadership teams

• Work within a highly regulated pharmaceutical/FDA environment

If you have 15+ years of operations leadership experience and a strong background in pharmaceutical, 503B, biotech, medical device, or other FDA-regulated operations, we encourage you to apply.