Neurocrine

Neurocrine

Director, Clinical QA

US CA San Diego · Director

Sponsorship not specified$182k-$248kDetected 9 days ago
GCPComplianceProduct ManagementAuditingClinical TrialsClinical ResearchGMPFDA RegulatoryCRISPRPharmacovigilanceResearchLeadershipCommunicationCollaborationMicrosoft OfficeGxPBiostatisticsRegulatory Affairs

About the role

  • Coordinates interdepartmental activities both internally and externally with regulatory, clinical, drug safety, and medical affairs to ensure clinical activities and internal functions meet quality standards and reflect risk-based principals.
  • Your Contributions (include, but are not limited to):
  • Participates in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs

Responsibilities

  • Develop and executive strategy for Clinical QA and establish strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives
  • Leads in the development, implementation, and enhancements to the clinical QMS
  • Supports investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities
  • Develops metrics and trending of compliance activities for Clinical Quality Assurance and communicate these to upper management as necessary
  • Oversees and may perform the internal audits designed to determine if policies/procedures, systems, reporting and/or the conduct of the investigational studies are executed with compliance to GCP principles/regulations

Requirements

  • Extensive GCP audits and inspections or related experience required.
  • Experience with developing and implementing GCP QA systems, process' and procedures.
  • Previous managerial experience also required.
  • Masters Degree in similar field as noted above AND 10+ years of experience as noted above
  • Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
  • Ability to mentor, be a trusted advisor, and an advocate for Quality with the ability to influence change and invest deeply in the company mission
  • Ability to integrate and apply feedback in a professional manner
  • In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines, and experience with international GCP regulations and guidelines is required
  • Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to investigator sites as well as management
  • 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 implementation

Compensation

  • The annual base salary we reasonably expect to pay is $181,800.00-$248,000.00.

Benefits

  • Lead effort in developing, implementing and communicating of the GCP QA vision, goals, core capabilities, and value while championing a strong Quality Culture

Company info

  • Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. ( *in collaboration with AbbVie )
  • At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
  • Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs.
  • We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders.
  • The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. ( *in collaboration with AbbVie )
  • At Neurocrine, strong leadership drives both business results and team success.
  • We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams.
  • Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
  • to relieve suffering for people with great needs.
  • Leads the company through pre-approval inspections and clinical audits.
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