A Quality Assurance Manager focuses on prevention of mistakes and defects in manufacturing products. Develops procedures to ensure that quality standards are maintained. Manages all steps related to quality assurance as part of the quality management strategy of a company. May involve leadership of a team of quality assurance supervisors, specialists, and other associated staff members.
Quality Assurance Manager - Life Sciences & GxP Operations at Premier Staffing Solution Quality Assurance Manager - Life Sciences & GxP Operations at Premier Staffing Solution in Stockertown, Pennsylvania Posted in 5 days ago.
Type:
full-time
Job Description:
The Quality Manager - Life Sciences & GxP Operations leads the quality function for life sciences warehousing and distribution operations. This position serves as the primary quality authority for operational quality, GxP compliance, quality systems, and client quality requirements. The role partners with clients, Operations leadership, and Quality personnel to maintain regulatory compliance, drive quality culture, manage audits and inspections, and continuously improve quality performance. Key Responsibilities Lead quality strategy, policies, procedures, and continuous improvement initiatives. Interpret and apply applicable GxP regulations, client requirements, and quality standards. Manage internal and external audits, regulatory inspections, investigations, CAPAs, risk assessments, and quality projects. Partner with Operations leadership to achieve quality, compliance, and performance objectives. Lead and develop Quality personnel and promote a strong quality culture across warehouse operations. Monitor quality metrics, trends, risks, and performance and provide recommendations for improvement. Serve as the primary quality contact for clients, including quality reporting, investigations, CAPAs, audits, inspections, and training. Maintain inspection readiness and support regulatory and client interactions. Evaluate regulatory and business changes and assess their impact on quality and compliance. Provide leadership, coaching, and training to promote quality awareness and accountability. Education & Experience Bachelor's degree in Biochemistry, Chemistry, Biology, Pharmaceutical Sciences, or related STEM field preferred. 7-10 years of experience in pharmaceutical, life sciences, quality, distribution, warehousing, or related regulated operations. Strong knowledge of GxP requirements and quality systems. Experience with audits, regulatory inspections, investigations, CAPA, risk management, and change control. Experience leading teams, cross-functional projects, and client-facing quality initiatives. Core Competencies GxP Compliance | Quality Assurance | Pharmaceutical Distribution | Audits & Inspections | CAPA | Risk Management | Quality Systems | Client Management | Leadership | Continuous Improvement
