Investigator I/II: Quality, Safety & Root-Cause

Biogen; North Carolina; On-site; USD 69,000 - 111,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Disability Insurance

Paid vacation and year-end shutdown

Holidays + personal days

Sick time

Parental leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking an Investigator in North Carolina to lead investigations into quality deviations and safety events across manufacturing operations. You will conduct interviews, analyze data, and develop CAPAs to reduce recurrence while ensuring compliance with QMS and regulatory expectations.

The role collaborates across functions and supports audits and continuous improvement. The position emphasizes structured problem solving, strong writing, and stakeholder management in a regulated

Qualifications

• Experience conducting investigations, root cause analyses, or operational problem-solving activities within regulated environments.
• Strong analytical and critical thinking skills with the ability to evaluate complex information and develop practical solutions.
• Excellent technical writing and documentation abilities.
• Strong facilitation, communication, and stakeholder management skills.
• Ability to effectively collaborate across multiple functions and levels of the organization.
• Working knowledge of quality systems, safety programs, and compliance requirements within manufacturing, laboratory, industrial, or regulated environments.
• Demonstrated ability to manage multiple priorities and meet critical deadlines.

Responsibilities

• Lead investigations for quality deviations, safety incidents, alert actions, and remedial action requests across manufacturing operations
• Conduct interviews, gather and analyze data, facilitate investigation meetings, and apply systematic cause analysis methodologies to identify root and contributing causes
• Author clear, concise, and compliant investigation reports within designated quality and safety systems
• Partner with cross-functional stakeholders to develop effective corrective and preventive actions (CAPAs) that reduce recurrence risk
• Ensure investigations are completed in alignment with Quality Management System (QMS) requirements, regulatory expectations, and established timelines
• Share investigative findings and lessons learned across the organization to drive continuous improvement and operational excellence
• Support complex and high-impact investigations as needed
• Present investigation outcomes and supporting documentation during internal and external audits

Job description

Biogen is seeking an Investigator in North Carolina to lead investigations into quality deviations and safety events across manufacturing operations. You will conduct interviews, analyze data, and develop CAPAs to reduce recurrence while ensuring compliance with QMS and regulatory expectations.

The role collaborates across functions and supports audits and continuous improvement. The position emphasizes structured problem solving, strong writing, and stakeholder management in a regulated