Merck · 15 hours ago
Director - QA Operations
Wilmington, DE
Full-time
Onsite
Director/Executive
$173K/yr - $273K/yr
15+ years expMerck is a leading global healthcare company committed to improving health and well-being. The Quality Assurance Operations Lead role involves establishing the Quality structure at the Wilmington Biotech Campus, ensuring compliance with cGMPs and regulatory requirements, and providing oversight for quality systems and processes.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Acting in the role of leading the Quality Assurance Operations team supporting drug substance and drug product manufacturing
Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP, the registered marketing authorization and the associated regulatory requirements
In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site
Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements
Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations
Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs
Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site
Be an advocate of continuous improvement in the Quality Management Systems
Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility
Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release
Drives opportunities for continuous improvement
Provide direct audit support and participate in response team for audits and inspections by Health Authorities
Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions
Qualification
Required
Minimum of 15 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations
At least 3 years of operational experience in a regulated environment
Experience in supporting tech transfer or process validation either internally or externally
5 years' experience in Antibody Drug Conjugate Process Development and/or Manufacturing
Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place
Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc)
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task and handle tasks with competing priorities effectively
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators
Strong operations support background ensuring value added and effective quality oversight
Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline
Preferred
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators is preferred
Capital Project experience preferred
Benefits
Medical
Dental
Vision healthcare
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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