About the Organization

We are a U.S.-based global pharmaceutical and biologics manufacturing enterprise supporting large-scale production of specialty therapeutics, sterile injectables, cell and gene therapy platforms, and complex biologic compounds distributed across North America, Europe, and Asia-Pacific.

Our manufacturing ecosystem operates within highly regulated FDA, EMA, and global GMP frameworks. Facilities include advanced sterile production lines, temperature-controlled biologics processing units, high-precision packaging environments, and validated distribution corridors supporting hospitals, specialty pharmacies, and clinical research partners.

As global demand for biologics and specialty pharmaceuticals increases, disciplined operational governance, compliance precision, production scalability, and cost containment are critical to ensuring patient safety and enterprise performance.

We are seeking a strategic and execution-focused Senior Operations Manager to lead production oversight, regulatory compliance coordination, operational efficiency initiatives, cross-functional integration, and performance optimization, fully remote within the United States.

This is not a plant-floor supervision role. This is a high-level operational performance leadership mandate.

Job Function

The Senior Operations Manager will oversee multi-site operational coordination, production performance management, GMP compliance adherence, cost optimization initiatives, and cross-functional alignment across manufacturing, quality, supply chain, and regulatory affairs.

This leader ensures production continuity, regulatory precision, and margin stability in a highly regulated pharmaceutical environment.

Essential Duties and Responsibilities

• Oversee operational performance across biologics and specialty pharmaceutical production lines

• Strengthen GMP compliance adherence and audit readiness frameworks

• Align production scheduling with demand forecasting and supply chain continuity

• Lead operational efficiency initiatives, improving throughput and reducing waste

• Implement KPI dashboards tracking yield rates, downtime, compliance metrics, and cost performance

• Guide cross-functional integration between Quality, Regulatory, and Supply Chain teams

• Support new product introduction (NPI) operational readiness

• Manage operational risk assessments and mitigation strategies

• Oversee workforce planning and operational resource allocation

• Contribute to capital investment planning for equipment modernization and automation

• Present operational performance updates to executive leadership

• Mentor mid-level operational managers and succession planning initiatives

Strategic Support

• Advise the VP of Manufacturing on production scalability and capacity optimization

• Support regulatory inspection preparation and remediation initiatives

• Contribute to M&A integration efforts for newly acquired manufacturing sites

• Align operational initiatives with ESG and sustainability performance goals

• Strengthen the digital transformation of manufacturing analytics systems

• Guide long-term cost optimization and margin protection initiatives

Job Qualifications and Requirements

• 12+ years of progressive operations leadership experience

• 5+ years within pharmaceutical, biologics, or highly regulated manufacturing environments

• Proven experience managing multi-site operational performance

• Strong knowledge of GMP, FDA, and global regulatory compliance standards

• Demonstrated success in leading operational efficiency and cost containment programs

• Experience working within large-scale manufacturing organizations

• Bachelor’s degree required; advanced degree in Operations, Engineering, or Business preferred

Personal Capabilities and Qualifications

• Strategic and performance-driven operational leader

• Strong executive communication and cross-functional collaboration skills

• High accountability for compliance, quality, and efficiency

• Analytical and data-informed decision-maker

• Resilient under regulatory and production pressure

• Governance-focused with disciplined execution style

• Strong mentorship and team development expertise

• Ability to lead distributed operations teams effectively

Working Conditions

• Fully Remote – United States

• Periodic domestic travel to manufacturing sites and compliance reviews (20–30%)

• High-accountability role tied to production continuity and compliance KPIs

• Executive-level visibility within manufacturing leadership

• Collaboration across distributed global manufacturing and quality teams

Compensation & Benefits

Total Compensation Package: $220,000 – $310,000 USD

Compensation Includes:

• Competitive base salary within stated range

• Performance-based annual incentive aligned with production and compliance metrics

• Long-term incentive eligibility, where applicable

• Comprehensive health, dental, and vision coverage

• 401(k) with employer contribution

• Remote work flexibility and home office support

• Professional development and industry certification reimbursement

• Generous PTO and paid holidays

Why Join Us

• Lead operational performance within a global life sciences enterprise, improving patient outcomes

• Influence production continuity for advanced biologics and specialty therapeutics

• Partner with executive leadership, driving next-generation pharmaceutical manufacturing

• Competitive compensation aligned with measurable operational impact

• Opportunity to strengthen enterprise-scale manufacturing governance in a mission-critical industry