Sr. Specialist CQA

Neurocrine Biosciences; San Diego (CA); On-site; USD 97,000 - 133,000; Full time

Job summary

Neurocrine Biosciences is seeking a Sr. Specialist, QA Operations to provide quality support for GMP manufacturing and drive compliance across product lifecycles in San Diego, CA. The role involves reviewing CGMP records, supporting NPI, and leading deviation investigations within cross-functional teams.

Required BS/BA with 4+ years or MS with 2+ years in pharma/biotech QA, strong communication, and knowledge of FDA/EU CGMPs. Eligible for annual bonus and comprehensive benefits.

Qualifications

• BS/BA in Life Sciences, Engineering, 4+ years QA in pharma/biotech.
• MS in Life Sciences, Engineering, 2+ years QA in pharma/biotech.
• Team player with strong communication and time management.
• Knowledge of FDA/EU CGMP regulations and ICH guidelines.
• Experience reviewing GMP quality records.
• Experience with investigation methodologies.
• Experience with electronic quality management systems.

Responsibilities

• Review quality records for CGMP compliance.
• Perform timely disposition of GMP products per regulations and internal procedures.
• Participate in project teams as QA representative and escalate issues as needed.
• Provide QA support for new product introduction (NPI) processes and changes.
• Interface with internal and external stakeholders to process quality records.
• Lead or participate in deviation investigations.
• Participate in change control for clinical and/or commercial products.
• May participate in audits of external suppliers.
• May participate in inspections and inspection readiness activities.
• Support continuous improvement across QA functions.

Skills

Quality assurance

CGMP knowledge

Regulatory knowledge

Documentation

Audit coordination

Deviation investigation

Root cause analysis

Electronic QA systems

Education

BS/BA in Life Sciences/Engineering

MS in Life Sciences/Engineering

Tools

Electronic QMS

Job description

Who We Are: 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 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)

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 a top place to work.

Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2025. We were also named a Great Place to Work Certified company.

About the Role

The Sr. Specialist, QA Operations is responsible for providing Quality support for GMP manufacturing under general supervision.

• Review quality records related to GMP products manufactured by Contract Manufacturing Organizations (CMO) for compliance to CGMPs
• Perform timely disposition of GMP products in accordance with applicable regulations and internal procedures
• Participate in project teams, serving as the QA representative and escalating issues to senior QA management when appropriate
• Independently provide Quality support for new product introduction (NPI) processes for new products and/or for substantial changes to existing products (e.g., new CMO, scale-up, process validation)
• Interface with internal and external stakeholders to process quality records and resolve issues
• Lead and/or participate in deviation investigation teams
• Participate in the change control process for changes related to clinical and/or commercial products
• May participate in or conduct audits of external suppliers
• May participate in compliance inspections and inspection readiness activities
• Support and interact with other Quality functional areas to ensure compliance with internal processes and procedures and to promote continuous improvement

Other duties as assigned.

Requirements

• BS/BA degree in Life Sciences, Engineering, or related field and 4+ years of experience in quality within the pharmaceutical or biotechnology industry OR Master’s degree in Life Sciences, Engineering, or related field and 2+ years of similar experience as noted above
• Works well in a team environment
• Ability to work closely with both internal and external personnel
• Strong organizational and time management skills
• Ability to meet multiple deadlines with a high degree of accuracy and efficiency
• Attention to detail, critical thinker and effective organizational skills
• Strong verbal and written communication skills
• Ability to quickly assess new information and communicate requirements to the appropriate individuals
• Basic knowledge of FDA and EU regulations and ICH Guidelines and their applicability to CGMP drug substance and drug product manufacturing
• Hands-on experience reviewing quality records related to GMP manufacturing (e.g., batch records, labeling, deviation reports, specifications, change controls, CAPAs)
• Ability to identify and elevate problems and follow-through with corrective actions
• Experience with investigation methodologies (e.g., fishbone diagrams, 5 Whys, pareto charts)
• Experience with electronic quality management systems

The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. 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 20% of the earned base salary and eligibility to participate in our equity based long term incentive program.

Benefits

• retirement savings plan (with company match)
• paid vacation
• holiday
• 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

Our Values

• PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.