Sr. Manager QA, Auditor

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

The 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) in order to uphold the requirements of the Swiss Establishment License(s) (ELs) held by Neurocrine Switzerland GmbH, in compliance with the Swiss Law SR 812.212.1, Medicinal Products Licensing Ordinance (MPLO), in particular, the responsibilities described in article 13, 15, 17, 22, 23 of the MPLO.

_

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 the rules of 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 EL(s) 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 any 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 all US and international regulations pertaining to GxP’s 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

#LI-OS1

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.

Please note that we are only able to consider applications from candidates who are eligible to work in Switzerland (Swiss/EU citizens or holders of a valid work permit).

We look forward to receiving your application and getting to know you!

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.