Quality Assurance Manager - Conshohocken, United States - LHH

Description

Our client in Conshohocken is hiring a Quality Assurance Manager to join their team

Job Type: Full-Time/Permanent

Hours: Monday Friday, 8:00 AM 5:00 PM - Onsite 5 days/week

Reports To: Director of Quality Assurance

Summary

The Quality Assurance Manager holds a pivotal role within our organization, tasked with the critical responsibility of ensuring that all products and services meet the established quality standards.

Responsibilities:

• Up-to-date understanding of FDA regulations, cGMP "Current Good Manufacturing Practice" and internal policies/procedures.
• Manage deviations, nonconformances, complaints, safety incidents, Corrective and Preventive Actions (CAPAs), and Supplier Corrective Action Requests (SCARs) ensuring prompt investigation and implementation of effective corrective measures.
• Conduct thorough root cause analyses and assessments of CAPAs to determine the adequacy of investigations.
• Establish, assess, and refine quality metrics, offering insights and recommendations to drive continuous improvement.
• Oversee the review of HCT/P donor records to ensure final product release aligns with standard operating procedures and regulatory/accrediting agency requirements.
• Supervise the review of quality control records, encompassing equipment cleaning, maintenance, environmental monitoring, and supply inspections.
• Contribute to training efforts on quality-related processes and corrective actions.
• Support the implementation of new projects and product development initiatives.
• Assist in the formulation of validation/qualification protocols and summary reports, adhering to regulatory requirements and industry best practices.
• Evaluate and authorize validation/verification protocols, execution data, and summary reports.
• Facilitate internal, client, and regulatory agency audits to guarantee compliance with regulatory and certification standards, as well as internal policies and procedures.
• Cultivate professional relationships with customers, partners, and vendors.
• Oversee direct reports and monitor individual performance.
• Maintain meticulous records in accordance with standard operating procedures.
• Participate in offsite business meetings and conferences to stay abreast of industry developments and trends.

Education & Experience:

• Bachelors degree required in biological science or related field.
• At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility.
• Valid Driver's license.

**If you or someone else you know are interested in this role, please send updated resumes to for immediate consideration**