Senior Specialist, Quality Assurance

Regulatory Toolkit; Pennsylvania; Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Merck & Co., Inc. seeks a Senior Specialist, Clinical Supplies Quality for Global Development Quality to ensure reliable clinical supply availability, quality, and regulatory compliance across clinical programs.

The role partners with Global Clinical Supplies, Regulatory Affairs, Device Development, and External Manufacturing to prevent disruptions in the development portfolio. The candidate will lead quality strategies, manage deviations and CAPAs, and drive continuous improvement in a highly

Qualifications

• Bachelors in a scientific discipline with relevant pharma/GMP experience, or advanced degree with additional years in the field.
• Familiarity with batch disposition (release) activities.
• Experience reviewing investigations, deviation support, and CAPAs.
• In-depth knowledge of cGMPs and regulatory requirements in pharma or related fields.
• Strong communication, leadership, and teamwork skills.

Responsibilities

• Collaborate with Global Clinical Supplies, Global Development Quality, Regulatory Affairs, and other functions to protect the clinical supply chain.
• Develop and execute quality and stakeholder strategies, driving improvement initiatives while leveraging technology.
• Evaluate and disposition clinical supply materials in conformance with policies and regulations.
• Coordinate and/or support investigations of deviations and significant quality events.
• Identify trends and resolve significant quality issues to ensure reliable clinical supply.

Skills

Clinical supply operations

Medical Device/Combination Products

Regulatory compliance (cGMP)

Stakeholder management

Process improvement

Cross-functional leadership

Education

Bachelor's Degree in Scientific Discipline

5+ years GMP/pharma experience

Tools

ERP/MES

Trackwise

SAP

PowerPoint

Excel

Job description

Job Description

Position Overview

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 ofClinical 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:

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.

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.

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.

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 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.

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

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.

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.