Senior QA Lead - External Manufacturing Oversight

Merck & Co.; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Paid holidays

Vacation

Sick days

Hybrid work arrangements

Job summary

Merck & Co., Rahway, NJ, seeks a senior leader to provide quality oversight for contractors supporting GMP activities. You will supervise external vendor QA, lead investigations, and ensure regulatory compliance across clinical finished goods and packaging.

The role requires a bachelor's degree with extensive pharma experience, leadership in cross-functional teams, and a track record of driving quality improvements within an R&D environment.

Qualifications

• Bachelor's degree required with 10+ years of pharma industry experience or advanced degree with 8+ years of experience.
• Strong knowledge in R&D activities and ability to interact with scientific SMEs on initiatives and issue resolution.
• Experience in Clinical Packaging and Labelling, Distribution of clinical supplies and dispositioning.

Responsibilities

• Act as Lead Quality Liaison for Quality Oversight of External Entities/CMOs.
• Oversee Third-Party Vendors in Clinical Finished Goods Platform.
• Lead investigations, approve deviations, CAPs, Change Controls, and lead cross-functional vendor reviews.

Skills

Audit Management

Batch Releases

Compliance Investigations

Deviation Management

GMP

Project Leadership

Quality Oversight

Quality Risk Management

Quality Systems Compliance

Regulatory Compliance

Education

Bachelor's Degree in Pharmacy, Biology, Engineering, Chemistry or related field

Job description

Merck & Co., Rahway, NJ, seeks a senior leader to provide quality oversight for contractors supporting GMP activities. You will supervise external vendor QA, lead investigations, and ensure regulatory compliance across clinical finished goods and packaging.

The role requires a bachelor's degree with extensive pharma experience, leadership in cross-functional teams, and a track record of driving quality improvements within an R&D environment.