

New · posted Nov 8
Merck · Pharmaceuticals
Senior Specialist, Quality Assurance
- West Point, PA
- Hybrid
- Full-time
- Senior & Principal
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.
Pay and benefits
$106,000 – $167,000 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 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, PAWorking 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:
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
Senior & Principal roles in the US65 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $106,000 | — | $167,000 |
| All US (middle half) | $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.
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.
- 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.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- 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
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
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%
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Senior Specialist, Quality Assurance at Merck
Applications close November 13. $106K–$167K a year, employer provided.


