Director, Site Quality

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Site Quality Leader is responsible for overseeing all quality and compliance activities at the Columbia manufacturing site and CMOs. This role provides strategic and operational quality leadership to ensure adherence to corporate policies and regulatory requirements. This leader will ensure robust quality systems, adherence to and efficiencies in quality processes, improve inspection readiness and oversee quality for external manufacturers. 
Reporting to the VP, Quality Operations TT division, the Site Quality Leader serves as the primary quality authority for the site, ensuring product quality, regulatory compliance, and alignment with the company’s Compliance Master Plan (CMP) and Quality Management System (QMS).

ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality Leadership & Strategy

• Provide strategic direction for all site quality functions, ensuring alignment with corporate quality objectives and regulatory expectations.

• Drive the timely execution of critical corporate initiatives and programs. 

• Lead the development, implementation, and continuous improvement of site quality systems, processes, and metrics.

• Serve as the site’s senior quality representative during regulatory inspections, internal audits, and customer audits.

• Champion a culture of quality, compliance, and operational excellence across all site functions.

Quality Systems & Compliance

• Ensure full compliance with FDA, ISO 13485, CMDR, EU MDR, JPAL, and other applicable regulations.

• Oversee the effectiveness of key quality system elements, including CAPA, nonconformance management, change control, document control, internal audits, training, and risk management.

• Drive timely and effective remediation of quality and compliance gaps, including those identified through the Compliance Master Plan (CMP).

• Ensure robust supplier quality oversight in partnership with corporate Supplier Controls leadership.

Manufacturing Quality Oversight

• Provide leadership for incoming inspection, in‑process quality, final release, and product disposition activities.

• Ensure that manufacturing processes are validated, controlled, and monitored to maintain product quality and regulatory compliance.

• Partner with Operations, Engineering, and Supply Chain to proactively identify risks, implement corrective actions, and improve process capability.

Cross‑Functional Collaboration & Stakeholder Management

• Collaborate with Regulatory Affairs, R&D, Operations, Supply Chain, and corporate Quality teams to ensure alignment and consistency across the organization.

• Communicate quality performance, risks, and improvement plans to site leadership and executive stakeholders.

• Influence and guide cross‑functional teams to ensure quality considerations are embedded in all business decisions.

People Leadership & Development

• Lead, mentor, and develop a high‑performing site quality team, including Quality Engineering, Quality Assurance, and Quality Control functions.

• Ensure the team has the skills, tools, and resources needed to meet quality and compliance objectives.

• Foster a collaborative, accountable, and continuous‑improvement‑oriented environment.

Performance Management & Reporting

• Establish and maintain site quality metrics, dashboards, and reporting mechanisms.

• Monitor trends, identify systemic issues, and drive data‑driven improvements.

• Provide regular updates to senior leadership on site quality performance, risks, and strategic initiatives.

QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, or related technical field; Master’s degree preferred.

• Minimum 12–15 years of experience in quality, manufacturing, or engineering within a regulated industry; medical device experience strongly preferred.

• Demonstrated success leading quality teams and managing complex quality systems in FDA‑regulated environments. Remediation and audit readiness experience preferred.

• Deep knowledge of cGMP, FDA regulations, ISO 13485, MDSAP, EU MDR, and other globa