Director, Contract Testing Laboratories Quality Oversight

Merck & Co.; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. in the USA is seeking a Director of Contract Testing Laboratories Quality Oversight to lead the external QA program for contracted testing and cell banking.

You will establish risk-based oversight, drive performance metrics, and ensure GLP/GMP compliance across global CTLs and storage with a focus on patient safety. The role requires a strong QA leadership background, experience with regulatory inspections, and the ability to travel about 30% to support multiple sites.

Qualifications

• Bachelor's degree in a scientific field required.
• 10+ years in Quality Systems, QA, or QC within pharmaceutical manufacturing under GMP and health authority 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.

Responsibilities

• Leads strategy, budget oversight and performance management of the CTLs and cell bank quality oversight organisation.
• Establishes and maintains a risk-based quality oversight model for contract testing laboratories.
• Establishes and maintains a risk-based quality oversight model for cell banking.
• Provides operational leadership to the contract testing laboratories for drug substance, drug product and finished product testing.
• Provides quality oversight of testing, storage and retention in line with regulatory expectations and GLP/GMP.
• Supports resolution of quality issues and OOS investigations that could impact launch or supply continuity.
• Oversees analytical technology transfer quality.
• Defines performance metrics and governance routines to monitor and improve quality and operational performance.
• Leads quality assessments for prospective contract test laboratories and new method citations, remediating gaps.
• Establishes and maintains quality agreements to protect company quality and compliance.
• Directs, mentors and develops a high-performing quality assurance team dedicated to external testing oversight.
• Promotes accountability, collaboration, operational excellence, and proactive problem-solving across the organization and external network.

Skills

Quality Assurance

GxP Compliance

Regulatory Inspections

Team Leadership

Risk Management

Travel readiness

External partner oversight

Education

Bachelor's degree in scientific discipline

Job description

Director, Contract Testing Laboratories Quality Oversight

The Director, Contract Testing Laboratories (CTL) Quality Oversight is a critical leadership role within our external Quality organization. The incumbent is accountable implementing Divisional and Company policies, procedures, and guidelines, and for Quality Assurance responsibilities for our company's contracted testing services globally. This role ensures that all product modalities (drug substance, drug product, finished product) tested at CTLs are analyzed and that cell banking manufacture and-storage is in accordance with Company standards and all applicable regulatory requirements, meeting both internal and external customer demands and protecting patient safety.

Primary responsibilities

• Leads the strategy, organisational design, budget oversight and performance management of the contract testing laboratories and cell bank quality oversight organisation.
• Establishes and maintains a risk-based quality oversight model for our company's contract testing laboratories.
• Establishes and maintains a risk-based quality oversight model for cell banking.
• Provides operational leadership to the contract testing laboratories accountable for drug substance, drug product and finished product testing.
• Provides Quality oversight of the contract testing laboratories to ensure products are tested, stored and retained in accordance with regulatory expectations, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and our company's requirements.
• Provides Quality oversight to resolve quality issues, out-of-specification (OOS) investigations, and deviations that could impact launch or supply continuity representing all using sites and functions.
• Provides Quality oversight for analytical technology transfer.
• Defines clear performance expectations, metrics and governance routines to monitor and improve quality and operational performance.
• Lead Quality assessments for prospective contract test laboratories or new method citing and ensure gaps are remediated appropriately.
• Establish and maintain Quality agreements to protect our company's quality and compliance requirements.
• Direct, mentor, and develop a high-performing team of quality assurance professionals dedicated to external testing laboratory oversight.
• Promote a culture of accountability, collaboration, operational excellence, and proactive problem-solving across the internal organisation and external testing network.

Education

Bachelor's degree in a scientific discipline required.

Required Experience and Skills

• Minimum of ten (10) years of experience 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.

Preferred Technical/ Functional Skills

• Advanced degree in a relevant scientific or technical field.
• Experience leading external partners across biologics or vaccines.
• Prior leadership of a multinational organization with direct accountability for partner performance, compliance, and supply support.
• Strong knowledge of quality governance models, supplier oversight, and risk-based quality management systems.
• Experience partnering with leadership at external partners to influence performance, strengthen quality systems, and accelerate remediation.
• Broader exposure to operations, engineering, supply chain, and commercial functions.
• Experience leading transformation, standardization, or continuous improvement initiatives.

Required Skills

Change Management, Change Management, Coaching, Data Integrity, Decision Making, Good Lab Practices, Interpersonal Relationships, Legal Compliance, Manufacturing Quality Control, Operational Efficiency, Operational Quality, Organizational Leadership, People Leadership, Performance Improvements, Performance Metrics, Performance Plans, Product Testing, Quality Assurance Processes, Quality Assurance Systems, Quality Auditing, Quality Control Management, Quality Control Systems, Quality Management, Quality Management Standards, Quality Measurements {+ 10 more}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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Primary location

USA - Pennsylvania - West Point

Compensation

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Remote

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/30/2026

Posting Notice

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.