New · posted Oct 23
Merck · Pharmaceuticals
Director, Contract Testing Laboratories Quality Oversight
- West Point, PA
- Hybrid
- Full-time
- Director
Closes Oct 30, 2026 · 8 days left
The role
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.
What you need
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.
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}
Travel Requirements
10%
Preferred Technical/ Functional Skillsnice to have
- 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.
What you'll do
- 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.
Pay and benefits
$173,000 – $273,000 a year
Employer providedAdditional 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
Medical, dental, vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
West Point, PAHybridOpen in Maps (opens in a new tab)
More jobs in West Point, PAWorking conditions
1st - Day
Hazardous Material(s)
n/a
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Remote
Job Posting End Date
10/30/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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:
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.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is:
USA - Pennsylvania - West Point
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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in the US107 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $173,000 | — | $273,000 |
| All US (middle half) | $185,500 | $209,000 | $233,750 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Lab testing and methods10
- GMP and compliance6
- Quality systems and risk4
- Documentation and SOPs2
- Investigations and CAPA2
- Regulatory submissions2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 17
- Open roles
- 17
- Distinct roles
- 6
- Locations
By discipline
- Regulatory11 65%
- Quality5 29%
- Compliance & Safety1 6%
By level
- Director9 53%
- Senior & Principal3 18%
- Associate & Specialist3 18%
More roles at Merck
- View role
Associate Director, Quality Assurance
Remote, USDirectorMedical Devices$142K–$224K
- View role
Associate Director, Drug Product, Quality Assurance
Wilmington, DE · HybridDirectorPharmaceuticals$142K–$224K
- View role
Director, Clinical and Regulatory Strategic Communications
North Wales, PADirectorPharmaceuticals$173K–$273K
- View role
Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)
Rahway, NJSenior & PrincipalPharmaceuticals$117K–$184K
Similar Quality Assurance roles elsewhere
- View role
Associate Director, Development Quality – OSD
Madrigal PharmaceuticalsConshohocken, PA +1 moreDirectorPharmaceuticals$169K–$198K
- View role
Director, Quality – New Product Development Lead
Madrigal PharmaceuticalsConshohocken, PADirectorPharmaceuticals$212K–$240K
- View role
Site Quality Head (Director)
NovartisMorrisville, NCDirectorPharmaceuticals$168K–$312K
- View role
Associate Director, Technical & CMC Support (PET Quality Operations)
LantheusRemote, USDirectorPharmaceuticals$139K–$232K
Director, Contract Testing Laboratories Quality Oversight at Merck
Applications close October 30. $173K–$273K a year, employer provided.