Sr. Principal Quality Scientist

Real; Minnesota; Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Annual incentive opportunities

Comprehensive benefits package

Job summary

Specialist Staffing Group is seeking an experienced Senior Principal Quality Scientist to provide regulatory quality leadership for R&D activities supporting regulated healthcare products in a hybrid Twin Cities, MN setting.

You will partner with cross-functional teams to maintain Quality Management Systems, ensure GLP/GMP compliance, and lead CAPA, change controls, and audits to support development through validation and lifecycle activities.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or related technical field.
• 6+ years in regulated medical device/pharma industry.
• 5+ years supporting analytical chemistry, microbiology, or regulated labs.
• Strong knowledge of Quality Management Systems (QMS) and quality engineering principles.
• Working knowledge of GLP and GMP requirements.

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 & reports, equipment qualification documentation, training plans, change controls, and investigation reports.
• 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.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

Analytical skills

Communication skills

Decision making

Education

Bachelor's degree in Engineering, Science, Quality, or related field

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

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.