QC Manager

Neurocrine Biosciences · San Diego, CA

RoleLantern checked

QualityFull-time$120k–$164kCompany career page

The apply link worked recently (not employer-confirmed).

Role summary

Neurocrine Biosciences seeks a QC Manager to oversee GMP analytical testing at contract sites and internal laboratory operations. The role involves reviewing analytical records, managing test method validation, coordinating with cross-functional teams, and ensuring regulatory compliance for clinical and commercial products.

What they're looking for

BS/BA in life sciences or related field with 6+ years pharmaceutical/biotechnology experience, or Master's degree with 4+ years similar experience
Working knowledge of CGMP requirements and quality systems in clinical and commercial drug manufacturing
Experience in analytical development and testing within a Quality Control environment
Strong data analysis and problem-solving skills with proficiency in root cause analysis
Knowledge of US FDA, European regulations, and ICH Guidelines
Proficiency with electronic document management, laboratory data management, and records systems
Leadership capabilities and ability to work effectively in cross-functional team settings

What you'll be doing

Review and approve analytical records for API and drug product stability data supporting retest periods
Oversee test method validation protocols, equipment qualification, and calibration records for GMP laboratory
Lead or participate in deviation investigations and change control processes for analytical modifications
Interact with contract testing labs and manufacturing sites to resolve analytical testing issues and conduct vendor audits
Prepare management reports on vendor performance and analytical findings; author regulatory submission modules

Privacy & handoff

This role links to Neurocrine Biosciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.

What RoleLantern checked

This role is listed from an approved source. RoleLantern checks that the application link is live and how recently the role appeared — the employer has not confirmed it directly on RoleLantern.

RoleLantern checked active

RoleLantern checkedPay range listed

Date posted1 day ago

Last source checkToday

Salary listedListed

Location clearClear

Something look off? Let us know and we may ask the employer to verify it.

See how you match this role

Upload your CV to see which of this role's requirements your background supports, where there may be gaps, and what needs clarification. Private by default — we never sell your CV.

See my match