About the RoleThe Manager/Sr. Manager Quality Auditor is responsible for planning, conducting, and reporting audits across global operations, supporting regulatory inspections, and driving continuous improvement in quality and compliance. Supports the Swiss Responsible Person (CH RP) to uphold the requirements of the Swiss Establishment License(s) held by Neurocrine Switzerland GmbH, in compliance with Swiss law and MPLO provisions as applicable.Your Contributions (include, but are not limited to)
Plan, conduct, and document internal, supplier, and third-party audits in accordance with global regulatory requirements
Evaluate compliance with international regulations and standards (e.g., FDA, EMA, ISO, ICH, MHRA, PMDA, and other regional authorities as applicable)
Assess the effectiveness of quality systems, procedures, and controls across global sites
Identify compliance gaps, risks, and trends; prepare clear audit reports with actionable findings
Partner with cross-functional teams to support root cause analysis and corrective and preventive actions (CAPAs)
Monitor CAPA implementation and verify effectiveness
Support regulatory inspections and health authority interactions, including preparation and follow-up activities
Maintain audit readiness and ensure alignment with evolving global regulatory expectations
Contribute to continuous improvement initiatives and quality system enhancements
Stay current on changes in global regulations and industry best practices
Ensuring the QMS is compliant with Swiss legislation for all GxP-related activities for Neurocrine Switzerland GmbH
Ensuring medicinal products under the oversight of Neurocrine Switzerland GmbH are procured, manufactured and supplied in accordance with GMP and GDP
Initiating, conducting and approving deviations, as applicable
Issuing, recording, and approving corrective and/or preventive actions (CAPAs), as applicable
Reviewing and approving change controls impacting a change in the scope of the Swiss Establishment Licences and reporting of notifiable changes to Swissmedic in accordance with MPLO Article 41
Supporting the CH RP for hosting inspections of Neurocrine Switzerland GmbH by Swissmedic and ensuring CAPA plans are implemented to address observations
Other duties as assigned
Requirements
BS/BA degree in life sciences or related field AND 6+ years of experience within Pharmaceutical/Biotechnology industry, including managing electronic documents management systems, learning management systems, document control, records, and training management activities OR
Master’s degree in life sciences or related field AND 4+ years of similar experience noted above
Strong working knowledge of global regulations and quality standards (e.g., FDA, EMA, ISO, ICH, Swissmedic)
Demonstrated experience conducting audits and managing audit findings
Excellent analytical, documentation, and report-writing skills
Ability to interpret complex regulations and apply them pragmatically
Strong communication and stakeholder-management skills
Willingness to travel internationally as required
Excellent computer skills
Experience in quality auditing, compliance, or quality assurance in a regulated industry
Experience as responsible person/QP preferred
Professional certifications (e.g., ASQ Certified Quality Auditor, ISO Lead Auditor), preferred
Experience auditing global suppliers and contract organizations
Familiarity with electronic quality management systems (eQMS)
Experience supporting regulatory inspections across multiple regions
Solid knowledge of US and international regulations pertaining to GxP and current industry trends as related to pharmaceutical, biological and gene therapy products
Extensive knowledge and expertise GDP and GMP systems throughout the product lifecycle
Strong working knowledge of global regulations and quality standards (e.g., FDA, EMA, ISO, ICH, Swissmedic)
Demonstrated experience conducting audits and managing audit findings
Excellent analytical, documentation, and report-writing skills
Ability to interpret complex regulations and apply them pragmatically
We are an equal opportunity employer. We welcome applicants eligible to work in Switzerland (Swiss/EU citizens or holders of a valid work permit).At our company, you’ll have the opportunity to make a real impact, take ownership of your work, and grow alongside a passionate and supportive team. We believe in open communication, mutual respect, and a collaborative environment where everyone’s ideas are valued.Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we encourage applicants even if experience or qualifications don’t line up exactly with the job description.
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