Director, External CTL Quality Oversight — Remote

MSD; United States; Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision coverage

401(k) retirement plan

Paid holidays

Vacation time

Compassionate and sick days

Job summary

MSD is seeking a Director, Contract Testing Laboratories Quality Oversight to lead the external QA program for contracted testing globally. You will design risk-based oversight across CTLs and cell banking, ensuring GLP and GMP compliance and rapid issue resolution.

You will build and guide a high-performing team, partner with external labs, and drive governance, performance metrics, and continuous improvement across the testing network.

Qualifications

• Minimum of ten (10) years of experience in Quality Systems, QA, and/or QC within pharmaceutical manufacturing under GMP/regulatory requirements.
• Proven track record managing complex quality investigations and risk assessments.
• Strong compliance background with regulatory inspections and health authority interactions.
• Demonstrated success leading and developing teams.
• Willingness to travel approximately 30% of the time, including short-notice travel.

Responsibilities

• Leads strategy, organizational design, budget oversight and performance management of CTLs and cell bank QA oversight.
• Establishes a risk-based quality oversight model for CTLs and cell banking.
• Directs QA oversight for testing of drug substance, drug product and finished products.
• Ensures GLP/GMP compliance and regulatory alignment across contracted laboratories.
• Resolves quality issues, OOS investigations and deviations impacting launch or supply continuity.
• Oversees analytical technology transfer and governance routines with measurable performance metrics.
• Mentors and develops a high-performing QA team and drives cross-functional collaboration.

Skills

Quality Assurance

Regulatory Compliance

Leadership

Risk Assessment

Data-driven Decisions

Travel Ready

Education

Bachelor’s degree in a scientific discipline

Job description

MSD is seeking a Director, Contract Testing Laboratories Quality Oversight to lead the external QA program for contracted testing globally. You will design risk-based oversight across CTLs and cell banking, ensuring GLP and GMP compliance and rapid issue resolution.

You will build and guide a high-performing team, partner with external labs, and drive governance, performance metrics, and continuous improvement across the testing network.