Director, Quality Control Analytical Sciences and Technology

About the role

Provides scientific and strategic leadership for analytical method lifecycle management within Quality Control. Accountable for ensuring analytical methods remain fit-for-purpose throughout their operational lifecycle through data-driven performance monitoring, investigation of method-related quality events, statistical trending, continuous improvement, and governance of analytical control strategies. Serves as the primary escalation point for complex OOS/OOT investigations, recurring invalid assays, adverse trends, and emerging method performance risks.

Responsibilities

• Analytical Method Lifecycle Governance
  • Provide strategic oversight of all GMP analytical methods throughout their operational lifecycle to ensure methods remain fit-for-purpose, compliant, and aligned with product and business needs.
  • Establish method ownership, lifecycle review processes, and performance governance.
  • Lead scientific assessment and approval of method changes, revisions, requalifications, and retirement activities.
  • Drive continuous improvement initiatives to enhance method robustness, reliability, and operational efficiency.
• Investigation and Scientific Problem Resolution
  • Serve as the highest-level scientific authority for analytical quality events and complex laboratory investigations.
  • Provide oversight and approval of significant OOS, OOT, deviation, atypical result, and recurring invalid assay investigations.
  • Lead root cause analyses involving methods, instrumentation, reagents, standards, training, and laboratory systems.
  • Identify systemic issues and implement sustainable corrective and preventive actions across the QC organization.
• Analytical Performance Monitoring and Data Analytics
  • Establish a proactive analytical monitoring program that uses data and statistical tools to ensure continued assay control and detect emerging risks.
  • Oversee control chart trending and monitoring of critical assay performance attributes, system suitability metrics, and laboratory performance indicators.
  • Evaluate trends, shifts, and recurring events to identify opportunities for risk mitigation and process improvement.
  • Develop and communicate analytical health metrics, dashboards, and periodic management reviews to QC leadership.
• Organizational Leadership and Cross-Functional Partnership
  • Build and lead a high-performing scientific organization that provides advanced technical support to QC Operations and the broader business.
  • Lead, develop, and prioritize the work of the AS&T team while ensuring appropriate resource allocation and succession planning.
  • Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on analytical strategy and issue resolution.
  • Serve as the analytical SME during inspections, audits, client interactions, regulatory submissions, and strategic business initiatives.
  • Direct activities of functional areas through direct reports. Represents Quality Control in interdepartmental meetings.
  • Occasional overnight travel by land and/or air may be required to attend seminars, conferences, or client meetings.

Requirements

• B.S. in Chemistry, Biochemistry, or Biology or related field with a minimum of 10 years of industry experience in a QC or analytical laboratory. MS or higher degree preferred.
• Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs, and regulatory audits.
• Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines.

Skills

• Strong team player with a positive attitude and readiness to tackle challenges.
• Exceptional written and verbal communication skills.
• Excellent multitasking and attention to detail.
• Strong relationship-building skills with team members, clients, vendors, or suppliers.

Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) matching.
• Paid time off.
• Performance-based bonuses.
• Opportunities for career growth and development.
• Supportive and inclusive work environment.

Pay

The compensation range for this role is $163,000 - $204,000 annually depending on experience and qualifications.

Schedule

• Full-time onsite position.
• Days and hours of work are Monday through Friday unless otherwise stated by Supervisor.
• Ability to work overtime and/or weekends when necessary.

Physical Demands & Work Environment

• Regular activities include sitting, standing, and walking.
• Occasional physically engaging tasks such as lifting objects up to 25 pounds.
• Possible exposure to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally.
• Reasonable accommodations available for individuals with different abilities.
• Visual acuity, including close, distance, and color vision, is essential.