New · posted Nov 6
Merck · Pharmaceuticals
Associate Director, Quality Assurance
- Rahway, NJ
- Hybrid
- Full-time
- Director
The role
The Associate Director is responsible for providing guidance to assure our Manufacturing division product quality complaint management processes are in compliance with worldwide medical device and combination product (MDCP) regulatory expectations. Responsible for a specific area of quality complaint management and serves as the subject matter expert; receipt and handling of product quality complaints, trending and reporting of global product quality complaint and/or Adverse Event Quality Investigation reporting for MDCPs. Maintains awareness of evolving industry and regulatory trends associated with complaint management. Assures strong linkages with other our Company divisions that are the business owners for associated processes e.g. adverse events, counterfeits, complaint intake, device/technical teams.
Primary activities include, but are not limited to:
- Maintain oversight of the complaint management process associated with receipt and handling of product quality complaints, trending and reporting of global product quality complaint and/or Adverse Event Quality Investigation reporting. Serve as the subject matter expert working with Global Safety, our Manufacturing division sites and External Business Partners to assure investigations and health authority reporting are completed in a timely manner and address any issues resulting from the investigations.
- Provides subject matter expertise to Quality Manual Chapter 8 and ensures chapter documentation is consistent with current regulatory expectations. Contributes to developing/revising policy and procedures.
- Provides regulatory inspection support to our Manufacturing division Sites as it relates to Product Quality Complaints and serves as the linkage between our Manufacturing division sites and Device Technology for device/design issues, between our Manufacturing division sites and Global Safety for pharmacovigilance, and between our Manufacturing division sites and Global Security for counterfeit management.
- Independently supports requests from internal and external partners as well and regulatory authorities regarding Adverse Event Quality or Product Quality Complaint issues. Directly works with the regulatory authorities to address issues and explain our Company processes.
- Leads/participates on cross-functional teams developing business processes and database applications that support the management/signaling of PQCs and/or potential AE Quality issues. Prepares recommendations to leadership to enhance processes assuring they are aligned with regulatory expectations. Continuously identifies opportunities for improvements to assure potential regulatory risks are mitigated.
- Analyzes issues from different points of view and look at multiple ways to define problems as they work across our Research & Development division, our Manufacturing division and Human Health. Additionally, as the position works with external partners who might have different practices then our Company the position must work to resolve issues to assure alignment with our Company's QMS.
- Identifies and resolves technical and operational problems, collaborating with peers to solve problems. Identifies continuous improvement opportunities to streamline the complaint management process, and develop consistent processes including the use of technology, automation, and artificial intelligence where applicable.
- Provides developmental feedback, coaching, and/or mentoring to other team members when necessary; in a positive and productive manner, using feedback to help others improve and succeed.
- Aligns staff activities with department objectives.
- Consults with management on decisions as needed
What you need
Required Skills
- Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management experience (ISO 14971:2012).
- Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
- A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
- Must work independently and have excellent interpersonal relationship skills with flexibility to adapt to fast pace environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.
Required Skills
Adaptability, Complaints Investigation, Creative Thinking, Cross-Functional Teamwork, Medical Device Regulations, Problem Resolution, Working Independently
- A Bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a Master’s degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 years of related experience
Experience
- 7 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
- LEADERSHIP: Requires established ability to manage and implement multiple projects/tasks simultaneously with competing priorities; managing time and personal/group effort. Requires established ability to identify and implement MPS principles and inclusive behaviors for continuous improvement. Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management. Strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment.
Travel Requirements
10%
Preferred Skillsnice to have
- Experience in Complaint Handling investigation process
- Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements)
Pay and benefits
$142,000 – $224,000 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, NJHybridOpen in Maps (opens in a new tab)
More jobs in Rahway, NJWorking 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
11/10/2026
*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:
$142,400.00 - $224,100.00
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 · November 6, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $142,000 | — | $224,000 |
This role: Merck's own published range.
Career trajectory
Where this role sits in Complaints & Post-Market Quality
The general path across 28 open Complaints & Post-Market Quality roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
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.
- Collaboration and leadership8
- Investigations and CAPA7
- GMP and compliance5
- Quality systems and risk4
- Clinical trial conduct3
- Documentation and SOPs2
- Regulatory submissions2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Complaints & Post-Market Quality work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 45
- Open roles
- 45
- Distinct roles
- 8
- Locations
By discipline
- Clinical28 62%
- Quality10 22%
- Regulatory7 16%
By level
- Director34 76%
- Associate & Specialist6 13%
- Senior & Principal4 9%
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Associate Director, Quality Assurance at Merck
Applications close November 10. $142K–$224K a year, employer provided.