Incoming Quality Control Manager

Job Responsibilities:

• Hire, train, and coach a team of QC individual contributors; run performance reviews and set goals tied to department metrics.
• Build a team culture centered on rigor, ownership, and continuous improvement.
• Translate technical quality issues into plain language for site leadership, clients, and inspectors.
• Maintain the material specification and sampling-plan program for raw materials, components, and container closure systems.
• Coordinate physical sampling, in-house and outsourced analytical testing, and the associated inventory transactions.
• Author and issue inspection records; represent the group in material-readiness and production-planning meetings.
• Drive disposition of nonconforming or held incoming materials and lead the resulting investigations.
• Manage the full physical testing program for pre-filled syringes and autoinjectors, including:
  Container closure integrity testing (CCIT) via high voltage leak detection (HVLD)
• Glide force, break-loose force, and extrusion force testing on a Zwick universal testing machine
• Needle cap/shield removal force and cap removal force testing
• Activation, trigger, and injection force testing for autoinjector devices
• Keep all test instrumentation (Zwick, HVLD, force gauges) current on calibration and equipment qualification.
• Review test data for trends and anomalies, escalating issues promptly.
• Lead or oversee OOS/OOT and nonconformance investigations using structured root-cause tools (5-Why, fishbone).
• Ensure investigations close on time with defensible root causes and effective CAPAs.
• Own QC documentation; sampling plans, test methods, specs, and investigation reports within the QMS/LIMS.
• Help prepare for and host regulatory and client audits touching incoming quality or physical testing.
• Align testing requirements with Quality Assurance, Manufacturing, technical/process teams, Supply Chain, and Engineering across development, tech transfer, and commercial production.
• Act as the physical-testing subject matter expert in client and regulatory conversations.

• Bachelor's degree in a life science or engineering discipline
• 7+ years in biopharma/pharma, including 3+ years managing people in a GMP environment
• 3+ years of hands-on QC physical testing experience with sterile injectables - pre-filled syringes and/or autoinjectors specifically
• Direct experience operating or managing Zwick testing equipment, HVLD instruments, and force gauges in GMP conditions
• Working knowledge of CCIT methodology, including HVLD
• Familiarity with relevant ISO standards for injection devices and quality systems (ISO 11608 series, ISO 23908, ISO 13485)
• Strong LIMS/JMP/Minitab or similar data-systems skills
• Experience participating in or hosting regulatory or client audits
• Able to pass annual vision screening, including color-blindness testing