Sr. Clinical QA Manager

Clinical Quality Assurance Lead

Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance ("QA") expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies / procedures.

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

• Primary Function
• Study Team Support
• Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles
• Develop risk mitigation plans and strategies
• 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
• Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management
• Provide GCP training as needed, including Investigator Meeting training
• Quality Systems
• Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training
• Proactively research, test and implement quality systems, processes and procedures within CQA area
• Develop and assess GCP metrics, 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
• Partner with QA management to drive strategies 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
• Secondary Functions
• Good Clinical Practice ("GCP") Audit Management
• Lead, plan, conduct, and 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 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 proactive audit status and metrics reports to management
• Other duties as assigned

Requirements :

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.

The annual base salary we reasonably expect to pay is $145,600.00-$211,150.00. 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.