New · posted Oct 16
Merck · Pharmaceuticals
Associate Director, Quality Assurance
- Rahway, NJ +1 more
- Hybrid
- Full-time
- Director
Closes Oct 19, 2026 · 4 days left
The role
The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our Company's Research Laboratory Quality Assurance and is responsible for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence and the Quality Management System (QMS).
The Associate Director, Quality Systems is responsible for execution, oversight, and continuous improvement of globally governed quality system processes in support of the clinical supply chain for investigational medicinal product within our company's Global network. The position strengthens the effectiveness, consistency, and sustainability of deviation management, CAPA, change control, quality risk management, and data governance during a period of heightened regulatory focus and organizational transformation.
What you need
Education Minimum Requirement
- B.S., M.S., or Ph.D. in a science or engineering discipline.
Required Experience and Skills
- Minimum 8 years (B.S./M.S.) or 5 years (Ph.D.) in the pharmaceutical or biotechnology industry.
- Demonstrated experience in Quality Systems, Quality Assurance, Compliance, or related GxP-regulated roles.
- Extensive working knowledge of global GxP requirements and Pharmaceutical Quality System principles.
Required Skills
Compliance Investigations, Data Integrity, Deviation Management, Good Manufacturing Practices (GMP), Managing Ambiguity, Process Standardization, Project Leadership, Quality Assurance Systems, Quality Compliance, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Training and Development
Travel Requirements
10%
Preferred Experience and Skillsnice to have
- Proven ability to drive continuous improvement and standardization across complex quality systems.
- Strong analytical, problem-solving, and decision-making skills.
- Effective oral and written communication, with the ability to influence across organizational boundaries.
- Experience working within globally governed models and partnering with site and functional stakeholders.
- Ability to manage ambiguity while maintaining rigor, consistency, and control.
- Effective negotiation skills and project management abilities
Skills named in this posting
What you'll do
The responsibilities of this role included, but are not limited to
- Drive Quality Systems Transformation initiatives focused on deviation management, CAPA effectiveness, change management, quality risk management, and data governance.
- Strengthen standardization and continuous improvement of global quality system processes to ensure consistent application, transparency, and inspection readiness.
- Reinforce data governance/ data integrity controls that underpin right-first-time execution and regulatory confidence.
- Provide quality system expertise to ensure processes remain in a state of control, compliant with global regulatory requirements and internal standards.
- Act as a change agent to enable durable quality system and quality culture improvements through system-level rigor, governance, and traceability.
- Partner cross-functionally with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
- Support management oversight activities by developing and monitoring quality system metrics and key performance indicators.
- Author, review, and approve quality system documentation and governance materials in accordance with established procedures.
- Maintain expert-level knowledge of GxP requirements, regulatory expectations, and industry trends, providing interpretation and guidance to stakeholders.
Pay and benefits
$129,000 – $203,000 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 and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
Rahway, NJ +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: West Point, PA
More jobs in Rahway, NJ +1 moreWorking conditions
1st - Day
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Hybrid
Job Posting End Date
10/19/2026
*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 - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$129,000.00 - $203,100.00
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 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in New Jersey10 roles publishing pay
Director roles in the US103 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $129,000 | — | $203,000 |
| New Jersey (middle half) | $168,750 | $206,000 | $209,875 |
| All US (middle half) | $186,000 | $209,000 | $231,000 |
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 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 866 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 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk12
- GMP and compliance6
- Collaboration and leadership5
- Data and digital systems4
- Investigations and CAPA3
- Lab testing and methods2
- Documentation and SOPs1
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
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 5
- Locations
By discipline
- Regulatory11 55%
- Quality8 40%
- Compliance & Safety1 5%
By level
- Director8 40%
- Senior & Principal6 30%
- Associate & Specialist6 30%
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Associate Director, Quality Assurance at Merck
Applications close October 19. $129K–$203K a year, employer provided.