Merck · 1 day ago
Mgr, Quality Control
Merck is a leading global healthcare company committed to improving health and well-being. The Manager of Quality Control is responsible for overseeing the administration of laboratories, ensuring compliance with regulations and guidelines, and driving continuous improvement in quality processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Drives continuous improvement and supports sustainability of implemented changes identified through such lean tools or champions new actions as a result of data obtained through lean methodology
Responsible for the necessary personnel and equipment resources to perform technical support, microbial testing, stability testing, release testing, supplies inspection, copy reading, API testing to ensure that customer expectations are met or exceeded
Aligns resources with business unit needs
Actively participates in Plant/Quality committees and works with other QO groups, Planning, Manufacturing, Packaging, Maintenance, and others as required to resolve problems, and satisfy quality and production needs
Responsible for knowledge of cGMP's, and laboratory safety, as well as the transfer of that knowledge to employees. Routinely makes decisions using cGMP and safety knowledge as a guide
Edits, writes, and/or approves departmental SOPs and investigations
Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas. Performs duties and responsibilities of the Director in his/her absence
Reports to the Quality Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only
Manages a staff of Associate Specialists, Specialists, and others as needed
Responsible for administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration
Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence
Manages QC area in accordance with company policy and applicable government regulations. Makes provisions to assure job responsibilities of the QC area are conducted in a timely and reliable manner to meet production demands
Ensures that all contemporary policies (SOPs, QSs, SATs, Departmental Policies,) are maintained and adhered to within the laboratory. Participates in the generation and interpretation of divisional policies/guidelines
Supports initiatives that involve the necessary human and capital resources needed to meet present and future QC needs and manages those resources to meet annual profit plan
Supports the achievement of plant objectives (e.g., metrics, productivity, etc.)
Applies leadership principles to testing operations
Performs other duties as assigned
Qualification
Required
B.A./B.S. degree (preferably in Science or Engineering)
Knowledge of continuous improvement principles
Minimum of 5 years of pharmaceutical experience
Administration Management
Analytical Method Transfer
Analytical Testing
Analytical Thinking
cGMP Compliance
Construction
Consulting
Corrective Action Management
Data Integrity
Driving Continuous Improvement
GMP Documentation
Instrumentation
Laboratory Analysis
Laboratory Operations
Laboratory Safety
Management Process
Medical Laboratory Technology
People Leadership
Pharmaceutical Quality Control (QC)
Product Lifecycle
Quality Control Management
Quality Management
Quality Standards
Regulatory Compliance
Preferred
Deviation Management / Root Cause Analysis
Background in technical writing
Experience with complex investigations and CAPA resolution
Experience applying 5S concepts
Experience with SAP, Data Integrity, cGMP, 21CFR requirements, ISO 13485, laboratory analysis principles and execution, MEDS, GLIMS, laboratory equipment qualification, method transfer, change control, and stability principles
Previous management experience
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.
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Recent News
2026-02-06
2026-02-05
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