Neurocrine Biosciences · 1 week ago
Assoc. Director, QC
San Diego, CA
Full-time
Onsite
Director/Executive
$161K/yr - $220K/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 Assoc. Director, QC will lead QC operations, ensuring the timely and compliant release of materials and oversee method lifecycle management while partnering with cross-functional teams to support clinical and commercial programs.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Review and approve API and drug product analytical records for clinical and commercial products
Review and approve stability data supporting retest period assignment for clinical and commercial products
Review and approve internal and external test method validation protocols and reports
Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab
Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate
Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues
Lead or participate in deviation and laboratory investigation teams
Facilitate the change control process for analytical changes related to clinical and commercial products
Prepare reports for management review of key statistics such as vendor performance based on findings from analytical record reviews
Author and review controlled documents, including Standard Operating Procedures, analytical methods, protocols and reports related to lab activities
Author and review analytical modules in regulatory submissions
Conduct and support audits of external vendors
Assist during onsite inspections and inspection readiness activities
May lead junior staff and/or cross-functional teams
Perform additional duties as assigned by management
Qualification
Required
BS/BA degree in life sciences or related field AND 10+ years of experience within Pharmaceutical/Biotechnology industry OR
Master's degree in life sciences or related field AND 8+ years of experience within Pharmaceutical/Biotechnology industry
Works well in a team environment with the ability to drive results
Ability to independently meet multiple deadlines, with a high degree of accuracy and efficiency
Capable of handling multiple responsibilities and prioritizing appropriately
Strong scientific data management and organization skills with attention to detail
Ability to identify and escalate problems and follow-through with 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
Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions
Apply problem-solving tools for root cause analysis
Excellent computer skills
Strong communication skills
Leadership capabilities and experience applying CGMP requirements in a Quality Control setting
Working knowledge of quality systems and regulatory compliance requirements within a clinical and commercial drug manufacturing operation
Experience in analytical development and/or testing in a Quality Control setting
Experience with using electronic documents management systems, laboratory data management systems, document control and records management
Knowledge of US FDA and European regulations and ICH Guidelines
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