Principal Investigator

WHAT WE ARE LOOKING FOR

We are seeking an experienced Principal QA Compliance professional to provide leadership and subject matter expertise within our QA Compliance organization.

This highly visible role partners cross-functionally with Operations, Manufacturing & Development, Engineering, Quality Control, and Quality Assurance to maintain a strong state of GMP and regulatory compliance across the site.

As a key Subject Matter Expert (SME), you will provide leadership and guidance across critical quality systems, including deviations/exceptions, CAPAs, complaints, remediation initiatives, investigations, and quality trending. You will also play a key role in regulatory inspections, continuous improvement initiatives, and the development of sustainable quality practices.

The position may provide direct supervision to Quality Engineers and will influence teams across the organization to drive timely, effective, and compliant outcomes.

YOUR ROLE

In this role, you will:

• Serve in a leadership role during regulatory agency inspections and external audits, including acting as an SME or Inspection Room Representative.
• Lead or support the development of inspection responses and ensure regulatory commitments are completed effectively and on schedule.
• Monitor and evaluate quality metrics and trends, including Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, and data trend analysis.
• Support the preparation and completion of Annual Product Quality Reviews (APQRs), identifying meaningful trends, shifts, and potential CAPA requirements.
• Write, review, and provide final approval for complaints, exceptions/deviations, CAPAs, root cause investigations, and related quality documentation.
• Conduct investigations within applicable compliance and quality systems when required.
• Apply strong technical and process knowledge to assess complex quality and compliance issues and develop appropriate solutions.
• Lead Kaizen, brainstorming, and continuous improvement initiatives across the site.
• Support annual and non-routine GMP training.
• Serve as the primary designee for the Quality Operations Manager when needed.
• Proactively maintain compliance with applicable U.S., EU, WHO, Brazilian, and Korean regulatory requirements.
• Provide day-to-day supervision and oversight of Operations Quality Engineers, as applicable.
• Partner across functions to strengthen quality systems, improve processes, mitigate compliance risks, and promote a culture of continuous improvement.

ADDITIONAL RESPONSIBILITIES

• Work in accordance with established safety, environmental, quality, and regulatory requirements and promptly report unsafe conditions or incidents.
• Support information requests from Corporate and other departments.
• Collaborate with corporate teams to advance global continuous improvement, validation, and supplier management programs.
• Support the QA Compliance Manager with special projects and assignments.
• Identify and implement quality assurance best practices that support site and organizational quality objectives.
• Perform other duties as assigned.

YOUR BACKGROUND

Education & Experience

• Bachelor’s degree in Life Sciences, Business, or a related field required; master’s degree preferred.
• 8–12 years of experience within the pharmaceutical industry, with significant experience in Quality Assurance, Quality Compliance, Quality Systems, or a related GMP-regulated function.
• Experience working with deviations/exceptions, CAPAs, complaints, investigations, root cause analysis, APQRs, quality metrics, and regulatory inspections.
• ASQ Certified Quality Inspector, Auditor, or related quality certification preferred.
• Knowledge of microbiology and chemistry is preferred.

Skills & Competencies

• Strong understanding of GMP requirements, pharmaceutical quality systems, and regulatory compliance.
• Strong technical writing and documentation skills, with exceptional attention to detail.
• Demonstrated ability to identify quality risks, process weaknesses, and systemic issues.
• Strong investigation, root cause analysis, and problem-solving capabilities.
• Ability to interpret quality data, recognize trends, and translate findings into appropriate corrective and preventive actions.
• Proven ability to operate effectively in a fast-paced, highly regulated environment while managing multiple priorities.
• Strong organizational skills and sound, consistent decision-making abilities.
• Ability to influence and collaborate effectively with employees and leaders across all levels of the organization.
• Proficiency with Microsoft Office applications.

WORKING RELATIONSHIPS

This position works closely with teams throughout the site, including Operations, Manufacturing & Development, Engineering, Quality Control, and Quality Assurance, as well as corporate teams and external suppliers.

The role requires a high degree of independent judgment and the ability to make sound quality and compliance decisions based on company policies, SOPs, GMP requirements, and applicable regulatory standards.