Vice President, Laboratory Operations

Vice President, Laboratory Operations

About the Role:

As Vice President of Laboratory Operations, you will drive strategic vision and operational excellence across our laboratory. Collaborating closely with other leadership, you will champion operational needs, spearhead cross-departmental initiatives, and optimize key performance indicators (KPIs) to enhance quality, capacity, turnaround time (TAT), and cost of goods sold (COGS). You will serve as the primary point of contact for delegated products, fostering strong partnerships and delivering clear, concise updates to executive leadership.

This role demands a strategic leader who can contribute to budget planning, monitor financial performance, and ensure efficient workflow, customer satisfaction, and employee engagement. You will build and lead high-performing teams, drive continuous improvement, and implement effective change management. As a visible role model, you will foster a positive work environment, develop talent, and represent the company during audits, client visits, and technical discussions.

Key Responsibilities:

• Strategic Leadership: Develop and execute strategic initiatives to optimize laboratory operations, focusing on quality, capacity, TAT, and COGS.
• Operational Excellence: Lead and manage high-performing teams, ensuring accountability for customer satisfaction and achievement of departmental KPIs.
• Financial Management: Contribute to budget preparation, monitor revenue, expenses, test volume, and FTE utilization.
• Stakeholder Communication: Serve as the primary contact for delegated products, providing succinct updates to executive leadership and building effective partnerships.
• Quality and Compliance: Ensure adherence to quality programs, ISO 13485 standards, FDA requirements (CLIA and QSR), GDP, and GCP/cGMP.
• Continuous Improvement: Drive continuous improvement initiatives, implement change management, and utilize Lean Six Sigma principles.
• Talent Development: Lead, coach, mentor, and develop team members, fostering a positive and engaging work environment.
• Representation: Represent the company during audits, client visits, and technical calls, influencing internal and external policy-making.

Qualifications:

• BS/BA degree (or equivalent) in a STEM-related field; Biological Sciences preferred.
• Minimum of 12+ years of relevant experience with a BS, 10+ years with an MS, or 7+ years with a PhD.
• 5+ years of experience overseeing manufacturing at a Director or Senior Manager level.
• Ability to travel up to 25%.
• Current California CLS or CGMBS license preferred.

Knowledge, Skills, and Abilities:

• Proven track record in maintaining Quality program procedures and ISO 13485 standards.
• Strong understanding of FDA requirements (42 CFR 493 and 21 CFR 820).
• Knowledge of Good Documentation Practices (GDP) and Good Clinical/Manufacturing Practices (GCP/cGMP).
• Experience managing product/process nonconformities, audit corrective actions, and CAPAs.
• Proficient in Microsoft Office Suite, particularly Excel.
• Excellent written and verbal communication skills, with the ability to influence change.
• Exceptional organizational, time management, and problem-solving skills.
• Proven ability to build and manage high-performing teams.
• Experience providing succinct and timely program updates to leadership.
• Knowledge and experience with Lean Six Sigma concepts and tools, manufacturing/engineering experience, and LDT laboratory operations.