Merck & Co, Inc

Associate Director, Quality Assurance

Merck & Co, Inc • $129K — $203K *
Rahway, NJ 07065In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree (BS/BA) or equivalent preferred.
  • Minimum of 5 years of experience in a relevant field.
  • Strong understanding of GCP and regulatory compliance in China.
  • Experience in conducting quality audits and risk assessments.
  • Ability to communicate effectively with diverse teams and stakeholders.

Responsibilities

  • Prepare and conduct QA audits, including extended stays in China.
  • Collaborate with colleagues in China to navigate local regulations and cultural considerations.
  • Analyze critical quality factors to identify potential risks for audits.
  • Perform routine and directed audits of various sites and suppliers.
  • Support the identification of audit schedules based on risk assessments.

Benefits

  • Comprehensive medical, dental, and vision healthcare for employees and families.
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, and sick days.
  • Opportunities for annual bonuses and long-term incentives.
Full Job Description
Job Description

Primary Responsibilities:
  • Prepares, conducts QA audits, including prolonged auditing in China, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
  • Collaborate with colleagues in China to understand cultural considerations, responsibilities for work in global studies and local regulations in the China related to GCP and new drug applications.
  • Able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risk-based audits.
  • GCP routine and directed audits of investigator sites, country offices, suppliers, , third party collaborations and due diligence activities.
  • In alignment with risk assessments and input from Japan/China Lead, support the QALs in the identification of audit substrate in China for scheduling, as appropriate.
  • Ability to travel to/within China; extended stay in country (2-3 weeks per quarter).
  • Travel: 75% - Asia Pacific (China), including ROW as needed.


Preferred:
  • Facilitates communication and alignment with key stakeholders related to quality events and audit findings.
  • Participate in Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as deemed appropriate by the QAL.
  • Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.


Skills:
  • Influence/Negotiation - Using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
  • Ownership and Accountability - Taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
  • Execution Excellence - Taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive.
  • Networking and Partnerships - Building partnerships; developing and leveraging relationships within and across work groups to achieve results.
  • Coaching and Development- Building self-insight; demonstrating an awareness of own strengths and development needs as well as the impact of own behavior on others; modifying behavior based on self-awareness to improve impact.
  • Talent Growth - Embracing continuous learning; actively identifying new areas for growth; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skills on the job and learning through their application.


Education:
  • Bachelor's degree (BS/BA) or equivalent preferred.
  • Minimum of 5 years of experience in a relevant field.

#eligibleforERP

Required Skills:
Accountability, Accountability, Action Plan Development, Adaptability, Audit Management, Building Partnerships, Compliance Investigations, Deviation Management, Global Program Development, Impact Analysis, Influencing Skills, Proactive Behavior, Proactive Thinking, Project Leadership, Project Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality Auditing, Quality Oversight, Quality Reporting, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance, Results-Oriented, Setting Performance Standards {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

The salary range for this role is
$129,000.00 - $203,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
75%

Flexible Work Arrangements:
Remote

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
10/12/2026
*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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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