Vice President, Laboratory Operations

5+ years of experience overseeing manufacturing at a Director or Senior Manager level.

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.

Experience providing succinct and timely program updates to leadership.

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.