Quality Systems Manager

Role Overview:A growing life sciences manufacturer seeks a QMS leader to elevate quality systems and ensure compliance to medical device and life sciences regulations. Exciting growth opportunities in a dynamic environment! Key Responsibilities:Quality Systems Management:Manage training programs to ensure regulatory compliance.Oversee the internal audit program.Supervise supplier qualification processes.Support audits and inspections, including compliance with certifications such as ISO 9001.Administer document control processes, including periodic reviews, metadata management, and quality assessments.Maintain and manage the electronic quality management system.Commissioning, Qualification, and Validation (CQV)/CSV:Review and approve CQV and CSV documentation.Maintain and oversee the validation schedule.Operational Support:Provide on-site quality assurance support.Conduct log reviews, audit trail evaluations, and business continuity testing.Assist with quality events and change management.Support the onboarding of new sites.Provide general assistance to the quality function and leadership team.Qualifications:Required:Bachelor's degree in Life Sciences, Engineering, or a related field.3-5 years of experience in quality assurance or quality systems management in a medical device environment.Preferred:Familiarity with ISO 9001 and ISO 13485 standards.3-5 years of experience in a GMP quality function.Knowledge of 21 CFR Part 11 and Part 211 compliance.Experience with internal and external audits.Understanding of validation processes (CQV/CSV) and supplier qualification procedures.

Created: 2025-02-10