Assoc. Director, QC

Neurocrine Biosciences

11d

About The Position

Responsible for leading QC operations, ensuring the timely and compliant release of raw materials, in-process samples, drug substance, and drug product performed by contract sites and internal GMP analytical laboratory operations. This role provides scientific leadership, oversees method lifecycle management, and ensures QC systems meet all applicable regulatory requirements (FDA, EMA, ICH, USP). Partners cross-functionally with Quality Assurance, Manufacturing, Regulatory Affairs, and CMC teams to support clinical and commercial programs.

Requirements

• 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

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees