Quality Control Leader – GMP/ISO Lab Operations

Bionostics, Inc.; Harvard (MA); Presencial; USD 92.000 - 151.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k plan

Employee stock purchase plan (ESPP)

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Paid time off and holidays

Descripción de la vacante

Bio-Techne Corp. is seeking a senior quality operations leader to manage day-to-day QC activities, including QC lab and Incoming QC, ensuring compliance with FDA cGMP and ISO 13485.

You will drive staffing, training, and continuous improvement across departments while partnering with Manufacturing, QA, Supply Chain, and R&D to resolve product quality issues. The role requires a bachelor's degree in a life sciences field, 8+ years in regulated labs, and 3-5 years of people leadership.

Formación

• Bachelor's degree in Chemistry, Biochemistry, Biology, or a related discipline.
• 8+ years of laboratory/quality control in regulated medical device/biotech/pharma environment.
• Minimum 3-5 years of people leadership experience.
• Demonstrated experience with FDA QSR/QMSR, ISO 13485, and cGMP requirements.
• Experience supporting FDA, ISO, customer, or notified body audits preferred.

Responsabilidades

• Manage and lead the team, including staffing, recruitment, training, development, appraisal, attendance, disciplinary issues, and effective problem resolution.
• Oversee daily functions of each department and identify opportunities for improvement.
• Drive training and development of team members and work with Supervisors to ensure goals.
• Organize and schedule workflow to ensure smooth operation of Incoming QC and QC lab.
• Provide direction and support to all QC-related functions.
• Align with senior leadership initiatives and support corporate goals.
• Maintain a regular on-floor presence using GEMBA techniques.
• Engage with personnel to understand challenges and implement changes.
• Lead continuous improvement initiatives aligned with department and business goals.
• Mentor and empower personnel to implement changes successfully.
• Support site goals and cross-functional collaboration with Manufacturing, QA, Supply Chain, and R&D.
• Establish and monitor quality control systems and stability testing programs.
• Lead investigations and CAPAs for OOS/OOT and deviations.
• Ensure readiness for FDA/ISO audits and regulatory findings.

Conocimientos

Leadership

FDA QSR/QMSR

ISO 13485

cGMP

Root cause investigations

Educación

Bachelor's degree in Chemistry/Biochemistry/Biology

Descripción del empleo

Bio-Techne Corp. is seeking a senior quality operations leader to manage day-to-day QC activities, including QC lab and Incoming QC, ensuring compliance with FDA cGMP and ISO 13485.

You will drive staffing, training, and continuous improvement across departments while partnering with Manufacturing, QA, Supply Chain, and R&D to resolve product quality issues. The role requires a bachelor's degree in a life sciences field, 8+ years in regulated labs, and 3-5 years of people leadership.