Senior Specialist, Quality Assurance

Merck & Co.; West Point (PA); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck & Co. in Pennsylvania (West Point) seeks a Senior Specialist, Clinical Supplies Quality to support the clinical supply chain, ensuring availability, quality and regulatory compliance of clinical materials for development programs.

The role requires collaboration across Global Clinical Supplies, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing to prevent disruptions and drive quality improvements.

Qualifications

• Bachelor's Degree in Scientific Discipline with 5+ years in pharma/GMP, or advanced degree with 6+ years.
• Familiarity with batch disposition (release) activities.
• Experience reviewing investigations, deviation management support, and CAPAs.
• In-depth knowledge of cGMPs and regulatory requirements in pharma or related field.
• Evidence of leadership, with strong oral and written communication skills.
• Demonstrated teamwork skills and collaboration.

Responsibilities

• Collaborate with Global Clinical Supplies, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing.
• Navigate high visibility situations to prevent disruption of the clinical development portfolio.
• Provide technical and quality expertise on clinical supply operations and new technologies.
• Develop and execute quality strategies and improvement initiatives.
• Evaluate and disposition clinical supply materials ensuring conformity to policies and regulations.
• Coordinate investigations of deviations and quality events and drive issue resolution.
• Identify trends and proactively address compliance gaps affecting quality.

Skills

CAPA Management

Detail-Oriented

Deviation Management

Medical Devices

Process Improvements

Quality Risk Management

Six Sigma

Teamwork

Education

Bachelor's Degree in Scientific Discipline

Advanced Degree in related field

Tools

ERP/MES

Trackwise

SAP

PowerPoint

Excel

Word

Job description

Job Description

Position Overview

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.
• 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.

Required Skills

• 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.

Preferred Skills

• 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.

#EligibleforERP

Required Skills

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

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. If you need an accommodation during the application or hiring process.

Equal Employment Opportunity Employer

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

Primary Location

USA - Pennsylvania - West Point

Salary Range

$106,200.00 - $167,200.00

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.

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.

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

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.

Requisition ID

R425974