Sr. Principal Quality Scientist

We are seeking an experienced Senior Principal Quality Scientist to provide quality leadership and oversight for research and development activities supporting regulated healthcare products. This individual will serve as a key Quality Subject Matter Expert (SME), partnering with cross-functional teams to ensure compliance with global quality and regulatory requirements while supporting laboratory operations, product validation activities, and quality management systems.

This role offers the opportunity to work alongside a multidisciplinary team of scientists and engineers developing innovative therapies and technologies in a highly regulated environment.

• Serve as the primary Quality SME for laboratory, drug product, and medical device development activities.
• Partner with R&D and Quality leadership to establish and maintain site-level quality procedures and compliance processes.
• Review and approve quality documentation, including:
• Verification and validation protocols and reports
• Laboratory studies and procedures
• Training plans
• Change controls
• Nonconformance and corrective action records
• Support internal and external audits by developing audit plans, participating in audit execution, and representing Quality during regulatory inspections.
• Lead and support quality system processes, including CAPA and nonconformance management.
• Collaborate with global sites to harmonize laboratory quality practices, procedures, and training programs.
• Promote a culture of compliance, quality excellence, and continuous improvement.

• Bachelor's degree in Engineering, Science, Quality, or a related technical field.
• 6+ years of experience in the medical device, pharmaceutical, biotechnology, or other highly regulated industry.
• 5+ years of experience supporting analytical chemistry, microbiology, or regulated laboratory environments.
• Strong understanding of Quality Management Systems (QMS) and quality engineering principles.
• Working knowledge of GLP and GMP requirements.
• Ability to work independently, make sound decisions, and effectively influence stakeholders.
• Strong communication, analytical, and problem-solving skills.

• Experience with EU GMP (Eudra Lex Volume
  4).
• Experience with ISO 13485 quality management systems.
• Familiarity with USP and related industry standards.
• Formal auditing training or certification.
• ASQ certifications (CQE, CQA, etc.) and/or Six Sigma certification.
• Experience with risk management methodologies.
• Understanding of scientific methods, test method development, and validation processes.
• Proven ability to manage multiple priorities in a fast-paced environment.

The ideal candidate is a collaborative quality leader who can navigate complex regulatory environments, drive compliance initiatives, and effectively partner with R&D teams to support innovative healthcare products from development through validation and ongoing lifecycle activities.

• Make an impact on products that improve patient outcomes and quality of life.
• Collaborate with leading scientists, engineers, and quality professionals.
• Contribute to a growing R&D organization focused on innovation and continuous improvement.
• Competitive compensation, annual incentive opportunities, and comprehensive benefits package.

We are seeking an experienced Senior Principal Quality Scientist to provide quality leadership and oversight for research and development activities supporting regulated healthcare products. This individual will serve as a key Quality Subject Matter Expert (SME), partnering with cross-functional teams to ensure compliance with global quality and regulatory requirements while supporting laboratory operations, product validation activities, and quality management systems.

This role offers the opportunity to work alongside a multidisciplinary team of scientists and engineers developing innovative therapies and technologies in a highly regulated environment.

• Serve as the primary Quality SME for laboratory, drug product, and medical device development activities.
• Partner with R&D and Quality leadership to establish and maintain site-level quality procedures and compliance processes.
• Review and approve quality documentation, including:
  • Verification and validation protocols and reports
  • Equipment qualification documentation
  • Laboratory studies and procedures
  • Training plans
  • Change controls
  • Investigation reports
  • Nonconformance and corrective action records
• Support internal and external audits by developing audit plans, participating in audit execution, and representing Quality during regulatory inspections.
• Lead and support quality system processes, including CAPA and nonconformance management.
• Collaborate with global sites to harmonize laboratory quality practices, procedures, and training programs.
• Promote a culture of compliance, quality excellence, and continuous improvement.