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Quality Systems Manager

2 months ago

Brunswick, Maine, United States MyKelly Full time
Quality Assurance Manager
Position Overview: The Quality Assurance Manager will oversee the quality management system, ensuring adherence to regulatory and industry standards within our manufacturing and analytical environments. This position entails organizing, directing, and executing audits, as well as facilitating regulatory assessments.
Primary Responsibilities: Develop and maintain a comprehensive quality management system to guarantee compliance with current Good Manufacturing Practices (cGMP) in production and analytical operations.Oversee the Standard Operating Procedure (SOP) framework for the Quality department, including the evaluation and endorsement of SOPs from other divisions. Set and uphold quality benchmarks, testing protocols, and product standards throughout the production process.Collaborate with suppliers to establish raw material specifications and testing methodologies.Revise and implement quality assurance protocols and documentation systems.Compile and assess product and process quality metrics, fostering ongoing enhancement.Lead the preparation program for inspections to ensure readiness for regulatory body evaluations.Conduct internal audits, formulate audit timelines, and supervise audit improvement initiatives.Educate staff on Quality Systems and ensure adherence to regulatory requirements.Examine and address Out of Specification (OOS) and Out of Trend (OOT) findings.Additional Duties:Establish and sustain an Internal Audit Program, engage in change management and investigations. Draft, revise, and approve departmental procedures, ensuring regulatory compliance. Stay informed on regulatory developments and implement necessary adjustments promptly.Qualifications and Skills:A Bachelor’s degree is required; an advanced degree (MBA, MS, or PhD) is preferred in a scientific, engineering, or related discipline.A minimum of 8 years of experience in regulated quality settings, preferably in pharmaceuticals.Proven experience in leading audits and assisting with regulatory inspections.Strong technical writing and review capabilities for laboratory investigations and regulatory documentation.Comprehensive knowledge of global regulations and robust problem-solving skills.Exceptional communication, negotiation, and leadership abilities.Knowledge and Expertise:Proficiency in laboratory systems and equipment (IQ/OQ/PQ), compendia (USP, EP, JP), and cGMP regulations.Advanced understanding of Quality Lab Systems (e.g., Trackwise, ComplianceWire) for investigations and document management.Strong organizational skills and strategic problem-solving capabilities.