Sr. Specialist CQA

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

Benefits offered by this job

Annual bonus

Equity-based LTIP

401(k) match

PTO

Health insurance

Dental/vision

Job summary

Neurocrine Biosciences is seeking a Sr. Specialist of QA Operations to provide quality support for GMP manufacturing under general supervision. The role involves reviewing quality records, dispositioning GMP products, and leading deviation investigations.

This position requires strong collaboration with CMOs, auditors, and internal QA teams. Ideal candidates have a BS/BA or Master’s in Life Sciences or related field with 2–4+ years of QA experience in pharma/biotech, excellent communication, and

Qualifications

• BS/BA degree in Life Sciences, Engineering, or related field with 4+ years of quality experience in pharma/biotech OR Master’s degree with 2+ years of similar experience
• Works well in a team environment
• Ability to work closely with internal and external personnel
• Strong organizational and time management skills
• Ability to meet multiple deadlines with accuracy and efficiency
• Attention to detail and critical thinking
• Strong written and verbal communication skills
• Ability to quickly assess new information and communicate requirements
• Knowledge of FDA and EU CGMP regulations and ICH Guidelines
• Experience reviewing quality records for GMP manufacturing
• Ability to escalate problems and drive corrective actions
• Experience with investigation methodologies
• Experience with electronic quality management systems

Responsibilities

• Review quality records related to GMP products manufactured by CMOs for CGMP compliance
• Dispostion of GMP products per regulations and procedures
• Participate in project teams as QA representative and escalate issues
• Provide QA support for NPI processes and substantial changes
• Interface with stakeholders to process quality records and resolve issues
• Lead or participate in deviation investigations
• Participate in change control for clinical or commercial products
• May participate in external supplier audits and inspections
• Support other Quality functions to ensure compliance and continuous improvement
• Other duties as assigned

Education

BS/BA degree in Life Sciences, Engineering, or related field

Master’s degree in Life Sciences, Engineering, or related field

Job description

Who We Are:

Neurocrine Biosciencesis 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)

About the Role:

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

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

• 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 escalate 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 fieldand4+ years of experience in quality within the pharmaceutical or biotechnology industry OR Master’s degree in Life Sciences, Engineering, or related fieldand2+ 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 escalate 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

#LI-RS1

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.

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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 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.