Neurocrine Biosciences · 1 week ago
Sr. Clinical QA Manager
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$148K/yr - $203K/yr
8+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with neurological disorders. The Sr. Clinical QA Manager will drive Clinical Quality Assurance activities across multiple therapeutic areas, ensuring compliance with regulatory requirements and company policies while providing leadership and training.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
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
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
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
Qualification
Required
BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred
Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines OR Master's degree in life sciences or related discipline and 6+ years of similar experience noted above
Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired
Demonstrated 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
Anticipates business and industry issues; recommends relevant process improvements
Demonstrates broad expertise or unique knowledge
Considered an expert within the company and may have external presence in area of expertise
Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
Ability to work as part of and lead multiple teams
Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
Excellent computer skills
Excellent communication, problem-solving, analytical thinking skills
Sees broader picture and longer-term impact on division/company
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management, strong project leadership skills
Preferred
Experience with gene therapy clinical trials is preferred
Benefits
Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
Retirement savings plan (with company match)
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase