QC Manager

Neurocrine Biosciences • San Diego, CA

3d • $119,700 - $164,000

About The Position

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

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 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/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

• annual bonus with a target of 30% of the earned base salary
• eligibility to participate in our equity based long term incentive program
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior