Sr. Quality Specialist

Merck is seeking a Contractor, Quality Assurance Facilities & Validation (F&V) to join its Quality leadership team at the Rahway, New Jersey site. This role offers an exciting opportunity to serve as a subject matter expert in Quality Operations, Facilities, and Validation during a major expansion of the site's clinical development capabilities. You will work closely with cross-functional teams to provide Quality oversight across cross-modality capital projects—guiding new and existing facilities through design, qualification, start-up, and ongoing operations. The successful candidate will ensure that quality systems and controls for investigational medicinal products strictly adhere to cGMP guidelines and internal standards while balancing operational efficiency in a dynamic clinical supply environment.

Responsibilities

• Support and execute cGMP quality assurance activities directly related to facilities, equipment, utilities, and automation assets for clinical trial material supply.
• Provide Quality oversight for the capital project lifecycle across design phases, qualification, operational readiness, and start-up for cross-modality facilities.
• Oversee key cGMP processes, including calibration, validation, change management, quality risk management, and root-cause quality investigations.
• Partner with rapidly expanding internal teams to establish strong quality oversight, collaborative communication, and effective cross-organizational alignment.
• Apply current industry best practices and benchmarks to the design, implementation, and maintenance of pilot/clinical-scale facilities and equipment.
• Ensure ongoing compliance with regulatory expectations, cGMP requirements, and active clinical drug filings.
• Identify operational efficiencies and implement value-added, pragmatic solutions to address complex compliance and technical challenges.
• Sustain existing facility operations and manufacturing readiness alongside new capital project developments.

Education

• Minimum Required: Bachelor’s degree in science, engineering, or a related technical discipline.
• Preferred: Advanced degree (Master's or Ph.D.) in science, engineering, or a related field.

Experience
Minimum Required:

• At least 8 years of experience within the Pharmaceutical or Biotechnology industry.
• Proven experience in Quality, Operations, or related functions at a pilot and/or commercial scale.
• Strong working knowledge and practical application of Current Good Manufacturing Practice (cGMP).
• Demonstrated working knowledge of capital project execution and facility operations.
• Strong interpersonal, negotiation, conflict resolution, and written/verbal communication skills.

Preferred:

• Direct experience in R&D, clinical trial supply material manufacturing, or clinical supply areas.
• Foundational knowledge across validation disciplines (equipment, utilities, automation, unit operations, process development, or technology transfer).
• Background in managing cross-functional technical teams and leading complex problem-solving initiatives.
• Proficiency in capital project lifecycles from concept through design and start-up.

Additional Information

• Location: Merck Site – Rahway, New Jersey.
• Scope: Focuses on Clinical Development, R&D, and Investigational Medicinal Products (IMP) supply facilities.