Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Associate Manager, Quality Assurance is responsible for overseeing quality systems and ensuring compliance with regulatory requirements and company standards. This role provides leadership for nonconformance investigations, production quality support, and sterility assurance activities to maintain product quality, patient safety, and operational excellence. Key Responsibilities
Nonconformance Management
Supervise the identification, documentation, investigation, and closure of nonconformance events. Ensure timely root cause analysis and implementation of corrective and preventive actions (CAPA). Review and approve investigation reports to ensure compliance with GMP and internal procedures. Monitor quality metrics and identify trends requiring escalation or improvement. Production Quality Support
Provide Quality Assurance oversight and support to manufacturing operations. Partner with Production, Engineering, Validation, and Supply Chain teams to resolve quality issues. Review batch records, deviations, and change controls to ensure product disposition decisions are made appropriately. Support process improvements while maintaining regulatory compliance. Sterility Assurance
Oversee sterility assurance programs for aseptic manufacturing processes. Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements. Review environmental monitoring data, media fills, and contamination control strategies. Collaborate with microbiology and manufacturing teams to investigate sterility-related events and implement corrective actions. Leadership and Compliance
Supervise and mentor QA personnel to ensure effective performance and professional development. Support internal audits, regulatory inspections, and customer audits. Promote a culture of quality and continuous improvement. Ensure adherence to quality policies, procedures, and documentation practices. Qualifications
Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or a related field. 5+ years of experience in Quality Assurance within pharmaceutical, biotechnology, or medical device manufacturing. Experience with nonconformance investigations, CAPA, and GMP regulations. Knowledge of aseptic processing and sterility assurance principles. Strong leadership, problem‑solving, and communication skills. Familiarity with FDA, EMA, and international regulatory requirements. Fluent in French and English. Preferred Qualifications
Previous supervisory or people‑management experience. Experience supporting aseptic or sterile manufacturing environments. Knowledge of risk management tools and continuous improvement methodologies. Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling than you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.
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Nonconformance Management
Supervise the identification, documentation, investigation, and closure of nonconformance events. Ensure timely root cause analysis and implementation of corrective and preventive actions (CAPA). Review and approve investigation reports to ensure compliance with GMP and internal procedures. Monitor quality metrics and identify trends requiring escalation or improvement. Production Quality Support
Provide Quality Assurance oversight and support to manufacturing operations. Partner with Production, Engineering, Validation, and Supply Chain teams to resolve quality issues. Review batch records, deviations, and change controls to ensure product disposition decisions are made appropriately. Support process improvements while maintaining regulatory compliance. Sterility Assurance
Oversee sterility assurance programs for aseptic manufacturing processes. Ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements. Review environmental monitoring data, media fills, and contamination control strategies. Collaborate with microbiology and manufacturing teams to investigate sterility-related events and implement corrective actions. Leadership and Compliance
Supervise and mentor QA personnel to ensure effective performance and professional development. Support internal audits, regulatory inspections, and customer audits. Promote a culture of quality and continuous improvement. Ensure adherence to quality policies, procedures, and documentation practices. Qualifications
Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or a related field. 5+ years of experience in Quality Assurance within pharmaceutical, biotechnology, or medical device manufacturing. Experience with nonconformance investigations, CAPA, and GMP regulations. Knowledge of aseptic processing and sterility assurance principles. Strong leadership, problem‑solving, and communication skills. Familiarity with FDA, EMA, and international regulatory requirements. Fluent in French and English. Preferred Qualifications
Previous supervisory or people‑management experience. Experience supporting aseptic or sterile manufacturing environments. Knowledge of risk management tools and continuous improvement methodologies. Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling than you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.
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Kontaktdaten:
Integra LifeSciences Switzerland Sàrl Recruiting-Team
