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Job description
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.
Key Responsibilities
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.
Required Qualifications
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.
Preferred Qualifications
Experience with EU GMP (EudraLex 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.
What Success Looks Like
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.
Why Join Us?
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.
Senior Principal Quality Scientist
Twin Cities, MN (Hybrid)
About the Opportunity
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.
Key Responsibilities
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.
Required Qualifications
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.
Preferred Qualifications
Experience with EU GMP (EudraLex 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.
What Success Looks Like
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.
Why Join Us?
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.
Desired Skills and Experience
EU GMP, EudraLex Vol 4, ISO 13485, 21 CFR Part 210, 21 CFR Part 211
EOE Statement
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.