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New · posted Nov 8

Merck · Pharmaceuticals

Senior Specialist, Quality Assurance

  • West Point, PA
  • Hybrid
  • Full-time
  • Senior & Principal
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EmploymentFull-time
DeadlineCloses Nov 13, 2026

The role

The Senior Specialist, Clinical Supplies Quality, Global Development Quality is responsible for support of the Clinical Supply Chain for clinical development programs for our company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced.  This position will have responsibility for support of US quality operations and disposition, global distribution planning and management, and acquisition integration.

Primary Activities

This position will require an in-depth close collaboration with the key stakeholder groups including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing, and Global Clinical Trial Operations as well as multiple functions within the clinical supply chain.  This position will also include navigating dynamic, high impact, and high visibility situations on a regular basis in relation to ensuring that our company's clinical development portfolio/pipeline is not disrupted due to issues with clinical supplies.

In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:

  • Provision of in-depth technical and quality expertise regarding clinical supply operations and integration, Medical Device/Combination Products, and new technologies.
  • Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and procedures and leveraging technology.
  • Evaluation and disposition of Clinical Supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.
  • Coordination and/or support the investigation of deviations and significant quality events.
  • Identification of trends and/or potential compliance gaps and proactively leading the resolution of significant issues affecting quality and ensuring reliable clinical supply chain.

What you need

Required Skills

Primary skills include but are not limited to:

  • Strong technical expertise in R&D activities specifically related to clinical supplies; experience in Medical Device/Combination Products and New Technologies is preferred
  • Strong compliance knowledge and understanding of regulatory agency regulations and requirements including proficiency in interpreting and applying cGMPs to R&D environment
  • Demonstrated experience working with external parties and stakeholders; ability to interact with and influence stakeholder subject matter experts and senior leaders
  • Demonstrated knowledge of continuous improvement methodologies; ability to manage complex cross-functional initiatives
  • Demonstrated leadership, including strategy development / deployment and experience with tangible delivered benefits.

Required Education/Experience

  • Bachelor’s Degree in Scientific Discipline with 5+ years relevant experience within the pharmaceutical industry or Good Manufacturing Practice (GMP) related field (including Technical, Engineering, Quality or Operations) or advanced Degree with 6+ years relevant experience.
  • Familiarity with batch disposition (release) activities.
  • Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs).
  • In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
  • Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
  • Demonstrated teamwork skills.
  • ·Attention to detail, flexibility and awareness of production and quality control problems.

Required Skills

CAPA Management, Detail-Oriented, Deviation Management, Medical Devices, Process Improvements, Quality Risk Management, Six Sigma, Teamwork

Travel Requirements

10%

Preferred Skillsnice to have

  • Ability to independently manage multiple priorities and projects.
  • Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
  • Demonstrated analytical and problem-solving skills.
  • Knowledge of Lean Six Sigma and Project Management.
  • Knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.

Preferred Skillsnice to have

Current Employees apply HERE

Current Contingent Workers apply HERE

Pay and benefits

$106,000 – $167,000 a year

Employer provided
How this compares

Additional 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 and sick days

  • Annual bonus eligibility

  • Long-term incentive eligibility

Where you'll work

West Point, PAHybridOpen in Maps (opens in a new tab)

More jobs in West Point, PA

Working 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

11/13/2026

*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:

EEOC Know Your Rights

EEOC GINA Supplement​

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:

$106,200.00 - $167,200.00

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 8, 2026

Salary intelligence

How the pay compares

This role's midpoint is 17% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$106,000 to $167,000 a year

Senior & Principal roles in the US65 roles publishing pay

Middle half $92,500 to $152,000, median $117,000
Annual base pay
Annual base payLowMedianHigh
This role$106,000—$167,000
All US$92,500$117,000$152,000

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, November 8, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 345 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Quality Technician · Quality Assurance Specialist

    $78K median96 open
  2. This role

    Senior & Principal

    Often: Senior Specialist, Quality Assurance · Quality Associate

    $117K median87 open
  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $142K median78 open
  4. Later

    Director

    Often: Director, Product Quality Leader, Biologics · Director, Quality

    $220K median71 open
  5. Later

    VP & Executive

    Often: AVP · DX Head of Regions Quality Management and Regulatory Affairs

    $325K median13 open

Skills DNA

What this role leans on

How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 5 linesLab testing and methods: 2 linesDocumentation and SOPs: 2 linesInvestigations and CAPA: 3 linesRegulatory submissions: 1 lineQuality systems and risk: 2 linesData and digital systems: 1 lineClinical trial conduct: 2 linesCollaboration and leadership: 9 linesGMPLab testingDocumentationInvestigationsSubmissionsQuality systemsData systemsClinical trialsTeamwork
  • Collaboration and leadership9
  • GMP and compliance5
  • Investigations and CAPA3
  • Lab testing and methods2
  • Documentation and SOPs2
  • Quality systems and risk2
  • Clinical trial conduct2
  • Regulatory submissions1
  • Data and digital systems1

Regulatory intelligence

The rules, regulations and standards behind this role

The regulations, guidance and standards that govern Quality Assurance work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.

Company hiring pulse

Merck on Regulatory Jobs

37
Open roles
37
Distinct roles
8
Locations

By discipline

  • Clinical20 54%
  • Quality11 30%
  • Regulatory6 16%

By level

  • Director25 68%
  • Senior & Principal6 16%
  • Associate & Specialist5 14%
See all 37 Merck roles

More roles at Merck

All 37 Merck roles

Similar Quality Assurance roles elsewhere

Senior Specialist, Quality Assurance at Merck

Applications close November 13. $106K–$167K a year, employer provided.

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