Merck & Co, Inc

Associate Director - Quality Assurance

Merck & Co, Inc • $129K — $203K *
Rahway, NJ 07065In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, or related discipline; advanced degree preferred.
  • Minimum of 8 years in Pharmaceutical/Biotechnology roles, particularly in Quality and Operations.
  • Strong knowledge of Current Good Manufacturing Practice (cGMP).
  • Experience with capital projects and facility operations impacting health authority regulators.
  • Excellent interpersonal skills in communication, collaboration, and conflict resolution.

Responsibilities

  • Execute GMP quality assurance activities for clinical trial material supply.
  • Support design phases and operational readiness of cross-modality capital projects.
  • Drive quality from design through qualification and operations of new facilities.
  • Develop relationships and provide Quality oversight of expanding partner groups.
  • Manage projects related to Quality oversight of GMP facilities.
  • Lead quality assurance activities for qualification and validation in a clinical environment.
  • Identify efficiency opportunities and implement value-added solutions.

Benefits

  • Hybrid work arrangements for flexibility.
  • Opportunity to work in a rapidly expanding clinical development environment.
  • Engagement with a growing team of professionals.
  • Involvement in significant capital projects that align with site mission.
Full Job Description
Job Description

The Associate Director, Quality Assurance will be responsible for quality leadership and subject matter expertise in Quality Operations, Facilities and Validation, and Low Bioburden facilities at the our company Rahway, New Jersey site. This position will serve an important role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following:

  • Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities.
  • Support the design phases and operational readiness of one or more cross-modality capital projects that are aligned with the expanding site mission.
  • Drive quality from design through qualification, start-up, and operations of new facilities as well as maintain and sustain existing operations and facilities.
  • Develop relationships with and provide Quality oversight of key partner groups that are commensurately expanding in size and scope of work.
  • Participate in a growing team of professionals enabling an expanding site asset base.


The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all relevant our company quality requirements and regulatory standards.

Essential Duties and Responsibilities:

  • Manage projects and tasks affiliated with Quality oversight of GMP facilities.
  • Lead and perform quality assurance activities related to qualification and validation of facility, equipment, and automation assets in a complex and rapidly changing clinical development environment. Assure compliance with cGMP, regulatory expectations, and clinical filings.
  • Provide Quality oversight of GMP processes, including calibration, qualification, validation, change management, quality risk management, batch record review, and quality investigations.
  • Enable the capital asset lifecycle through phases from design through start-up to deliver and sustain compliant manufacture & testing of clinical trial material.
  • Build effective, collaborative working relationships and create effective communications within and across organizations.
  • Identify efficiency opportunities; propose and implement value added solutions.
  • Demonstrate a Quality mindset while balancing operational needs to develop pragmatic solutions to complex, technical and compliance challenges.
  • Ensure current industry best practices and benchmarks are applied to design and implementation of new GMP facilities and equipment.


Education Minimum Requirement:

  • Bachelor's degree in science, engineering, or related discipline; an advanced degree is preferred.


Required Experience, Knowledge, and Skills:

  • Minimum of 8 years of experience in Pharmaceutical / Biotechnology industry role(s). Experience in Quality, Operations, and/or related functions at pilot and/or commercial scale. Strong knowledge and application of Current Good Manufacturing Practice (cGMP). Working knowledge of capital projects and facility operations regarding the impact to health authority regulators as well as interpretation and application of GMPs. Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.


Preferred Experience and Skills:

  • Leadership of cross-functional teams and problem-solving situations. Technical knowledge or proficiency in one or more elements of validation, facilities, equipment, utilities, automation, systems, unit operations in various product modalities, or associated technologies. A combination of experiences foundational to knowledge of validation - in product or process development, engineering, scale-up, manufacturing, technical operations, technology transfer, facilities, equipment, automation, quality systems, and / or quality operations. Advanced ability to identify and solve complex problems in a timely and efficient manner. Knowledge and/or experience with capital project lifecycle. Experience in R&D or clinical supply areas and processes.


#eligibleforERP

Required Skills:
Compliance Investigations, Conflict Management, Cross-Functional Project Management, Deviation Management, Good Manufacturing Practices (GMP), Operational Quality, Project Leadership, Project Life Cycle Management, Project Risk Assessments, Quality Assurance Systems, Quality Auditing, Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance, Strategic Thinking

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Merck & Co, Inc

More Pharmaceuticals & Biotech Jobs

Find similar Associate Director - Quality Assurance jobs:

NationwideRahway, NJ