Industry: Global Pharmaceutical Manufacturing & Biologics Production
Division: Global Manufacturing & Supply Operations
Location: Raleigh-Durham | Basel | Dublin | Onsite / Hybrid Leadership Model
Reports To: Vice President, Global Operations
About the Company
We are a global pharmaceutical and biologics manufacturing organization producing life-saving therapies across oncology, immunology, rare diseases, and advanced biologic treatments. Our network includes FDA- and EMA-regulated facilities operating under strict GMP standards, supporting global distribution across 60+ countries.
Our manufacturing footprint integrates high-containment production suites, sterile fill-finish facilities, cold-chain logistics, and advanced quality control laboratories. As demand for complex biologics accelerates and regulatory scrutiny intensifies, operational precision, compliance discipline, and production scalability are critical to patient outcomes and global supply continuity.
We are seeking a highly strategic and execution-focused Director of Operations to lead site-level and multi-site operational performance across regulated pharmaceutical manufacturing environments.
This is not a plant supervisor role. This is a cross-functional operational leadership mandate within a highly regulated industry.
Job Function
The Director of Operations will oversee end-to-end manufacturing performance, production scheduling, quality alignment, supply chain coordination, workforce management, and continuous improvement initiatives within biologics and pharmaceutical production facilities.
The role requires balancing regulatory compliance, production efficiency, cost optimization, and patient-focused delivery timelines.
Essential Duties and Responsibilities
- Lead daily manufacturing operations across GMP-regulated production facilities
- Oversee production planning, resource allocation, and capacity optimization
- Ensure strict adherence to FDA, EMA, and global regulatory standards
- Drive operational KPIs, including yield, cycle time, OEE, and on-time delivery
- Partner with Quality Assurance to maintain audit readiness and compliance
- Optimize supply chain integration for raw materials and cold-chain logistics
- Implement lean manufacturing and continuous improvement initiatives
- Lead cross-functional coordination between Engineering, Quality, and Supply Chain teams
- Oversee workforce planning, staffing models, and performance management
- Manage operational budgets and cost control strategies
- Guide validation processes for new production lines and product launches
- Lead root cause investigations and corrective action initiatives
- Ensure operational resilience during supply disruptions
Strategic Support
- Contribute to long-term capacity expansion planning
- Support regulatory inspection readiness and global audit processes
- Align site-level operations with corporate production strategy
- Participate in capital expenditure planning for facility upgrades
- Assist in post-acquisition operational integration
- Support sustainability initiatives aligned with environmental compliance standards
Job Qualifications and Requirements
- 10–15+ years of progressive operations leadership experience
- 5+ years within pharmaceutical, biologics, or highly regulated manufacturing environments
- Deep understanding of GMP and global regulatory compliance frameworks
- Proven track record managing production teams within FDA/EMA-inspected facilities
- Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies
- Strong knowledge of supply chain coordination in temperature-sensitive environments
- Demonstrated ability to manage multi-functional teams
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, or Operations Management required; advanced degree preferred
- Lean Six Sigma Black Belt or equivalent certification preferred
Personal Capabilities and Qualifications
- Strong leadership presence in regulated manufacturing settings
- close attention to detail and compliance discipline
- Analytical and performance-driven mindset
- Resilient decision-maker under production pressure
- Strong cross-functional collaboration skills
- Data-driven operational problem-solving capability
- Ethical orientation aligned with patient safety standards
- Ability to inspire accountability and continuous improvement
Working Conditions
- Primarily onsite leadership presence is required
- Fast-paced, regulated production environment
- High accountability tied to patient-impacting delivery timelines
- Interaction with regulatory inspectors and audit teams
- Periodic travel between regional manufacturing sites
Compensation & Benefits
Total Compensation Package: $170,000 – $265,000 USD
Compensation Includes:
- Competitive base salary within stated range
- Performance-based annual bonus
- Comprehensive health, dental, and vision coverage
- Retirement savings plan with employer contribution
- Professional development and certification sponsorship
- Paid time off and global holiday schedule
- Wellness and employee assistance programs
- Relocation assistance (if applicable)
Why Join Us
- Lead operations supporting life-saving biologic therapies
- Influence production performance in a globally regulated industry
- Partner with scientific and quality leaders at world-class facilities
- Competitive compensation aligned with operational impact
- Career growth within global pharmaceutical leadership pathways
- Opportunity to make a measurable impact on patient access worldwide
