Assoc. Director, QC

We are seeking an Assoc. Director, QC to lead QC operations, ensure timely and compliant release of raw materials, in-process samples, drug substance, and drug product, and provide scientific leadership and oversight of method lifecycle management.

Requirements

• 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
• Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate
• 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