COMPANY OVERVIEW
Our client- Pharmaceutical company – is looking for Quality Assurance Project Manager.
This position needs to report to close to Somerset WI office hybrid (2-3 times a week)
RESPONSIBILITIES
QA Infrastructure Development at CMO Site
Lead the setup and implementation of QA systems.
Define and establish quality processes including document control, batch record review, deviation management, and quality risk management.
Oversight of Manufacturing and QC Activities
Monitor and ensure compliance of manufacturing and QC operations with cGMP, internal SOPs, and applicable U.S. regulations .
Review and approve critical quality documents, including master batch records, protocols, and reports.
Regulatory and Inspection Readiness
Support preparation and execution of regulatory submissions (e.g., IND, BLA) by ensuring QA compliance of manufacturing-related documentation and data.
Prepare for and participate in internal and external audits and inspections; lead or support resolution of audit findings.
REQUIREMENTS
Excellent verbal and written communication skills, with the ability to effectively convey complex quality-related information across all levels of the organization.
Strong interpersonal and leadership skills to manage cross-functional teams and foster a culture of quality.
Proficiency in Microsoft Office Suite, including advanced skills in Word and Excel for documentation, reporting, and data analysis.
Demonstrated expertise in analytical thinking and problem-solving, with a proactive approach to identifying and mitigating risks in quality processes.
In-depth knowledge of quality management systems and current Good Manufacturing Practices (cGMP).
Ability to lead audits, manage compliance, and oversee continuous improvement initiatives.
SALARY
USD $ 120,000 - 170,000
BENEFITS
Medical Dental Vision 401K and others.
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