Senior Specialist, External Capabilities Validation & Compliance (GxP Compliance & Documentation), Pharmaceutical Analysis & Digital Technologies

Merck is hiring a Senior Specialist in External Capabilities Validation, GxP Compliance & Documentation for its Pharmaceutical Analysis & Digital Technologies (PADT) team at the Rahway, Union County, NJ research facility.

Key Responsibilities

• Lead external capabilities validation projects to ensure compliance with GxP regulations.
• Develop, review, and maintain documentation for analytical methods, validation protocols, and compliance records.
• Collaborate with global analytical teams to drive a culture of quality, risk‑based thinking, and operational excellence.
• Support audits, inspections, and regulatory submissions by providing evidence of compliance and corrective actions.
• Mentor junior staff on GxP best practices and documentation standards.

Qualifications & Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering or related field; advanced degree preferred.
• Minimum 5 years of experience in GxP‑regulated environments, preferably within pharmaceutical analysis or digital technology labs.
• Strong knowledge of FDA, EMA, ICH guidelines and documentation lifecycle.
• Proven project‑management skills with ability to handle multiple validation activities simultaneously.
• Excellent written and verbal communication skills.

Compensation

Annual salary: $176,311.33

Location

Rahway, Union County, New Jersey, United States

Frequently Asked Questions

What type of experience is required for this Senior Specialist position?

At least 5 years of experience in GxP‑regulated pharmaceutical analysis or digital technology environments, with strong knowledge of FDA, EMA, and ICH guidelines.

Will the role involve travel or work at other Merck sites?

The primary work location is the Rahway, NJ research facility, but occasional travel to other Merck sites may be required for audits or project collaboration.

What are the key responsibilities of the Compliance Senior Specialist?

Leading external capabilities validation, maintaining GxP documentation, supporting audits and regulatory submissions, and mentoring junior staff on quality practices.