QC Manager

Socket.dev; San Diego (CA); On-site; USD 120,000 - 164,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Health benefits

Retirement plan with company match

Job summary

Neurocrine Biosciences is seeking a QA/QC leader to oversee GMP analytical testing at contract sites and internal labs in San Diego. You will review API and drug product records, stability data, validation protocols, and equipment qualifications to ensure compliance with CGMP and regulatory requirements.

You'll work with cross-functional teams, external labs, and manufacturing sites, lead deviation investigations, manage change controls, and prepare management reports.

Qualifications

• BS/BA in life sciences or related field with 6+ years in Pharma/Biotech OR
• Master’s in life sciences or related field with 4+ years of experience
• Strong team player with ability to drive results
• Ability to manage multiple deadlines with high accuracy
• Experience with CGMP and regulatory compliance in QC
• Experience with analytical development/testing and data management

Responsibilities

• Review API and drug product analytical records for clinical and commercial products
• Review stability data supporting retest period for products
• Review test method validation protocols and reports
• Review equipment qualification, calibration, and maintenance records
• Lead/develop deviation and investigation teams
• Facilitate change control processes for analytical changes
• Prepare management reports with key stats from analytical reviews
• Author/review SOPs, methods, protocols, and regulatory documents
• Conduct audits of external vendors and support inspections

Skills

Quality systems

CGMP

Regulatory compliance

Leadership

Data management

Analytical testing

Document control

Team collaboration

Problem-solving

Communication

Auditing

Education

BS/BA in Life Sciences

Master’s in Life Sciences

Tools

LIMS

EDMS

ELN

MS Excel

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)

About the Role:

Responsible for oversight of GMP analytical testing performed by contract sites and internal GMP analytical laboratory operations.

_

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

• 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 elevate 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

Requirements:

• BS/BA degree in life sciences or related field AND 6+ years of experience within Pharmaceutical/Biotechnology industry OR

• Master’s degree in life sciences or related field AND 4+ years of similar experience noted above

• 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 elevate 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

#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.

_

The annual base salary we reasonably expect to pay is $119,700.00-$164,000.00. 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 30% 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.