Quality Manager III

We are seeking a highly skilled Quality Manager III with a strong engineering background to join our Quality Validation team. This role is pivotal in ensuring the integrity of computerized systems and equipment within a high-stakes biopharmaceutical manufacturing environment. The ideal candidate will bridge the gap between technical engineering requirements and rigorous regulatory compliance, focusing on computerized system validation (CSV) and equipment qualification.

• Lead and execute computerized system validation (CSV) and computerized equipment qualification projects to ensure compliance with global regulatory standards.
• Direct and manage Corrective and Preventive Action (CAPA) activities, ensuring thorough root cause analysis and timely implementation of effective solutions.
• Serve as the primary quality interface for engineering and manufacturing teams, fostering a culture of compliance while maintaining operational efficiency.
• Simultaneously manage multiple high-priority projects, ensuring all deliverables meet strict deadlines without compromising quality.
• Apply deep working knowledge of Quality System Regulations (QSR) and FDA requirements to daily operations and long-term validation strategies.

• Bachelor's or Undergraduate Degree in Engineering, Life Sciences, or a related technical discipline.
• Master's Degree.
• 6–9 years of experience in the pharmaceutical or biopharmaceutical industry (related manufacturing environments also considered).
• Proven track record in Computerized System Validation (CSV).
• Hands‑on experience with MES and ERP (SAP) systems.
• Demonstrated experience working within FDA-regulated environments.

• Strong working knowledge of Quality System Regulations and computerized equipment qualification.
• Exceptional verbal and written communication skills, capable of translating complex technical data for diverse stakeholders.
• Highly detail-oriented with the ability to navigate complex documentation and strict timelines.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook).

• Strong Microsoft (Excel, Word, Outlook) skills.
• Work environment:
  Office setting, team of 4, free parking.
• Interview process:
  Zoom or possibly in person.