Quality Manager III
Swiftwater, Pennsylvania, United States
Job Description
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.
- 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.
- pply 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.
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