Director, Global CTL Quality Oversight (Remote)

MSD; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

MSD is seeking a Director to lead the CTL Quality Oversight for external testing and cell banking. You will drive strategy, governance, and risk-based oversight to ensure GLP/GMP compliance and patient safety across global contracted testing services.

The role requires a bachelor’s in a scientific discipline and 10+ years in quality systems with a strong track record in investigations, regulatory interactions, and leadership. Travel ~30% is expected.

Qualifications

• 10+ years in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements.
• Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions.
• Strong compliance background with experience supporting regulatory inspections and health authority interactions.
• Demonstrated success leading and developing teams.
• Ability to travel approximately 30% of the time, including occasional short-notice travel.

Responsibilities

• Leads the strategy, organisational design, budget oversight and performance management of CTLs and cell banking QA oversight.
• Establishes risk-based quality oversight model for CTLs and cell banking. Oversees GLP/GMP compliance and analytical testing.
• Provides operational leadership to QA teams ensuring testing, storage and retention meet regulatory requirements.
• Oversees investigations, OOS, deviations impacting launches or supply continuity; drives remediation and corrective actions.
• Mentor and develop a high-performing QA team and promote accountability and collaboration across sites.

Skills

Change Management

Coaching

Data Integrity

Decision Making

Good Lab Practices

Regulatory Compliance

People Leadership

Quality Auditing

Quality Management

Product Testing

Education

Bachelor's degree in science

Job description

MSD is seeking a Director to lead the CTL Quality Oversight for external testing and cell banking. You will drive strategy, governance, and risk-based oversight to ensure GLP/GMP compliance and patient safety across global contracted testing services.

The role requires a bachelor’s in a scientific discipline and 10+ years in quality systems with a strong track record in investigations, regulatory interactions, and leadership. Travel ~30% is expected.