Senior Specialist, Quality Assurance – Non-Sterile Product Quality Operations

Job Description

Senior Specialist, Global Development Quality Operations based in Rahway, NJ, is responsible for independently approving documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in support of our clinical supply programs. The role also independently approves documentation accompanying the disposition of excipients, components, and critical supply items to ensure conformance to regulatory and company requirements. Responsibilities include performing or coordinating audits of batch documentation, data, procedures, equipment, systems, and facilities to ensure compliance with SOPs, GMPs, and other applicable regulations, issuing reports summaries, and working with areas to resolve audit findings.

The position may also advise supported areas on quality requirements, serve as Development Quality representative for in‑house/outsourced manufacturing, oversee program‑related activities, review and approve batch records, deviations, and out‑of‑specifications, develop SOPs, and represent Development Quality on inter‑departmental teams.

• Minimum 5 years of experience in the pharmaceutical or related industry
• Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support, or clinical development
• Strong leadership skills with ability to lead cross‑functional teams including senior management representatives
• Excellent verbal and written communication, including presentation skills
• GMP or related drug regulation knowledge and expertise
• Ability to independently manage multiple priorities and projects

• Experience in non‑sterile and/or sterile drug product manufacture/testing
• Experience with excipient/component release requirements/testing
• Experience with manufacturing investigations and CAPA’s
• Familiarity with R&D or clinical supply areas and processes
• Knowledge and competency in SAP
• Experience with regulatory or QP inspections
• Superior collaboration, teamwork, and conflict management skills
• Strong analytical problem‑solving skills

Initially assigned to 1st shift (7:00 AM–3:00 PM) through the end of 2025 and into 2026, the position is expected to transition to 2nd shift (3:00 PM–11:00 PM) in 2026. Applicants must be willing and able to accept this schedule change.

Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three on‑site days per week (Monday–Thursday) with Friday as a remote‑working day, unless business‑critical tasks require on‑site presence. The model does not apply to field‑based, facility‑based, manufacturing‑based, research‑based, or remote‑designated positions.

$ – $ (range based on education, experience, skills, and other factors). Eligible for annual bonus and long‑term incentive if applicable.

Comprehensive package including medical, dental, vision, and other insurance benefits for employee and family; retirement benefits including 401(k); paid holidays; vacation and compassionate/sick days. More information available at the benefits portal.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Merck & Co., Inc., Rahway, NJ, USA. We do not accept unsolicited assistance from search firms for employment opportunities. All CVs or resumes submitted by search firms without a valid written agreement will be deemed the sole property of Merck.

Final date to receive applications and detailed instructions are stated in the posting. Please apply before the deadline listed.