Quality Manager III

Job Description:

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, specifically focusing on computerized system validation (CSV) and equipment qualification.

Key Responsibilities:

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.

Requirements:

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.

Skills:

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).

Nice to have:

Strong Microsoft (Excel, Word, Outlook) skills.

Work environment:

Office setting, team of 4, free parking.

Interview process:

Zoom or possibly in person.