Sr. Quality Engineering Manager

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:Provides senior-level Quality Engineering leadership across the medical device product lifecycle, ensuring compliance with regulatory standards and effective risk management in development and manufacturing activities. Serves as a subject matter expert and partner to cross-functional teams, leading complex investigations, supplier quality oversight, and quality system improvements. Drives data-informed quality strategy and operational excellence through KPI monitoring, risk mitigation, and continuous improvement initiatives supporting device constituents.

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Your Contributions (include, but are not limited to):

• Provide Quality Engineering leadership across the product lifecycle, ensuring effective quality oversight for medical devices and combination products

• Lead and facilitate complex risk management activities (e.g., Hazard Analysis, FMEA, PFMEA), ensuring alignment with applicable regulatory standards and integration of risk-based decision making across development and manufacturing processes

• Oversee and ensure the integrity and completeness of the Design History File (DHF) for medical devices and combination products, providing guidance to cross-functional teams on documentation strategy and regulatory expectations

• Lead complex investigations and root cause analyses related to device constituents, driving cross-functional collaboration to identify risks, implement corrective actions, and ensure sustainable outcomes

• Serve as a subject matter expert on applicable regulations and standards (including ISO 13485, ISO 14971, ISO 10993), advising cross-functional teams and guiding compliant device development and lifecycle management activities

• Drive the development, monitoring, and continuous improvement of Key Performance Indicators (KPIs) utilizing multiple data sources to identify trends, inform quality strategy, and enable data-driven decision making

• Assess, prioritize, and mitigate quality and compliance risks associated with manufacturing processes, recommending and implementing improvements to strengthen quality systems and operational performance

• Provide strategic updates and risk-based insights to senior leadership on program status, quality metrics, and emerging issues, proactively escalating critical concerns and recommending mitigation strategies

• Participate in supplier quality oversight activities, including evaluation, qualification, and ongoing performance monitoring of device component suppliers

• Lead supplier audits and ensure effective follow-up of audit observations to maintain supplier compliance and continuous improvement

• Oversee non-conformance management and failure investigations for device constituents, ensuring effective CAPA/SCAR implementation and sustainable resolution of systemic quality issues

• Provide expert Quality Engineering guidance internal stakeholders supporting medical device and combination product development, ensuring alignment with regulatory expectations and internal quality standards

• Drive continuous improvement initiatives within the quality system, contributing to the advancement of processes, tools, and best practices that support organizational quality objectives

• Perform other responsibilities as assigned in support of departmental and organizational priorities

Requirements:

• BS/BA degree AND 8+ years of relevant experience OR

• Master’s AND 6+ years of related experience OR

• JD or PharmD or PhD AND 4+ years of related experience

• Ability to independently problem-solve and execute and monitor corrective actions

• Ability to interpret data and analyze trends to provide insight into potential issues

• Strong communication, facilitation, planning, problem-solving, and organizational skills appropriate to experience level

• Excellent attention to detail, well organized and able to work independently and as a team

• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact preferred

• Practical experience in FDA and ISO regulated environments

• Knowledgeable in technical guidance documents from FDA, EMA, PDA, ISPE, ICH, ISO, PIC/S and other organizations for drugs, biologics, and medical devices, and able to apply the content of these to new and existing manufacturing processes

• Experience with medical device evaluation and production including planning processes, process controls, capability analysis, material control, acceptance sampling and measurement systems

• An understanding of CGMPs and their applicability to everyday work

#RS-1

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.

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The annual base salary we reasonably expect to pay is $148,500.00-$203,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.