Clinical Quality Assurance Manager

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Good Clinical Practice ("GCP") Audit Management:

  • Coordinate, conduct, and/or oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures

  • Develop and lead with the guidance of their supervisor the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable.Assist in the audit site selection process for study-specific audit plans. Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs

  • Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker

  • Provide audit status and metrics reports to management

• Study Team Support:

  • Serve as the CQA Lead for assigned studies

  • Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary

  • Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance

  • Support study-specific regulatory inspection activities at clinical investigator sites by leading and or coordinating site inspection preparation activities and reviewing inspection findings and responses in conjunction with QA management

  • Provide GCP training as needed, including Investigator Meeting training

• Quality Systems:

  • Work with a multidisciplinary team to help standardize clinical development activities within and across programs through preparation of SOPs and personnel training

  • Implement quality systems, processes and procedures within CQA area

  • Conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on continuous improvement initiatives

• QA Department Support:

  • Work closely with QA management to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned

  • Support all on-site regulatory inspection activities

  • May work on other projects within QA not related to GCP

• Other duties as assigned

• The ideal candidate will live in the San Diego County area

• BA/BS in life sciences or related discipline or RN and 6+ years of related experience in scientific or health care field, including in CQA in drug development environment is preferred. Industry experience. Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines including research of principal investigator regulatory histories. OR

• Master's degree in life sciences or related discipline and 4+ years of similar experience noted above

• In-depth knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired

• Ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to auditees as well as the Company's management

• Ability to identify and escalate problems and follow-through with the corrective actions

• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors

• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals

• Must possess strong verbal and written communication skills along with sound organization skills applicable to audit planning, reporting and archiving

• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines

• Works to improve tools and processes within functional area

• Developing reputation inside the company as it relates to area of expertise

• Ability to work as part of and lead multiple teams

• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent verbal and written communications, problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management skills

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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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