Merck · 8 hours ago
Director, Quality Assurance - Hybrid
USA - New Jersey - Rahway
Full-time
Hybrid
Director/Executive
$173K/yr - $273K/yr
12+ years expMerck is a leading pharmaceutical company seeking a Director of Quality Assurance at their Rahway, New Jersey site. This role involves overseeing quality assurance activities related to sterile drug product production and ensuring compliance with regulatory standards while leading a team of professionals.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Lead and perform quality assurance activities (e.g., review and approve GMP documentation) related to internally and externally sourced sterile drug products in a complex and rapidly changing clinical development environment
Support sterile drug product manufacturing in compliance with cGMP, regulatory expectations, and clinical filings
Provide Quality oversight of formulation, process and analytical development activities
Provide Quality oversight of investigations of events or deviations to support batch release and facility control decisions
Enable ongoing start-up of a new, state-of-the-art sterile filling line
Support evaluation, introduction, and installation of new processes, technologies and capabilities
Support design and operational readiness of sterile manufacturing facility expansion
Build effective, collaborative working relationships and create effective communications within and across organizations and with all stakeholder functions and levels
Identify improvement/efficiency opportunities and propose and implement appropriate solutions
Provide a Quality mindset while balancing operational needs to develop pragmatic solutions to complex, technical and compliance challenges
Support activities necessary to achieve GMP compliant and continuous clinical supply
Serve as steward for knowledge management and capability build within team
Manage program assignments and facility coverage
Qualification
Required
Bachelor's degree in science, engineering, or related discipline; an advanced degree will be preferred
Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry role(s)
Experience in Quality and manufacturing operations of sterile drug products, at pilot and/or commercial scale
Strong knowledge and application of Current Good Manufacturing Practice (cGMP) for sterile product manufacturing (e.g., Annex 1) and the application of Quality Risk Management principles
Technical understanding and knowledge of manufacturing processes and unit operations for sterile and/or large molecule products
Leadership of cross-functional teams, investigations, or problem-solving situations
Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution
Preferred
A combination of experiences in sterile product formulation, development, process development, manufacturing, technology transfer, scale-up, facilities, quality systems, and / or quality operations
Advanced technical knowledge in one or more elements of sterile products, processing, sterile dosage forms and associated technologies
Advanced ability to identify and solve complex problems in a timely and efficient manner
Experience in R&D or clinical supply areas and processes
Experience with leading, growing and developing teams
Experience with facility design and start-up
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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