Role Overview

Investigator II independently leads and manages moderate- to high-complexity quality investigations related to manufacturing, engineering, facilities, equipment, and validation systems. This role assesses product quality, patient impact, and regulatory significance using a science- and risk-based approach; performs comprehensive root cause analyses; develops robust investigation reports, CAPAs, and effectiveness strategies; and ensures compliance with site procedures, regulatory requirements, and data integrity standards. Investigator II collaborates cross-functionally with subject matter experts and business partners to resolve complex quality events, support timely product disposition decisions, and drive continuous improvement initiatives.

Key Responsibilities

• Independently lead end-to-end investigations related to manufacturing, facilities, engineering, equipment, validation, and other cross-functional quality events.
• Collect, review, and evaluate supporting investigation data, including manufacturing records, equipment logs, environmental monitoring data, maintenance records, validation documentation, and historical quality events.
• Conduct investigations related to facility and environmental monitoring excursions.
• Demonstrate the ability to prioritize and dynamically adjust workload based on business needs, product impact, and organizational priorities.
• Perform comprehensive risk and impact assessments related to product quality, patient safety, data integrity, and regulatory compliance.
• Timely Prioritize investigation activities and timelines to support patient batch disposition and release decisions using a robust risk-based approach and impact assessment, leveraging the required SMEs.
• Conduct detailed root cause analyses using various structured methodologies.
• Develop and own CAPA investigations; ensure timely closure and proper effectiveness checks.
• Drive and owns investigation meetings, cross-functional alignments and support resolution of complex quality events.
• Rapidly learn and develop a strong understanding of new manufacturing, engineering, validation, and facility processes to support effective and efficient investigations.
• Collaborate closely with SMEs, Quality leads, and cross-functional stakeholders to ensure investigations are thorough, scientifically sound, and inspection-ready.
• Support internal audits and regulatory inspections, including presenting investigation, findings, and conclusions to auditors and inspectors.
• Ensure all investigations are completed in accordance with established quality standards, regulatory requirements, and defined timelines.
• Contribute to continuous improvement initiatives related to investigation processes, documentation practices, systems, and quality tools.
• Demonstrate strong analytical thinking, critical reasoning, and problem-solving skills when evaluating complex quality events.
• Analyze investigation and deviation trends to identify recurring issues, systemic risks, and opportunities for proactive process improvements.
• Author clear, concise, and scientifically justified investigation reports suitable for regulatory review and inspection scrutiny.
• Provide guidance and technical support to junior investigators and cross-functional teams on investigation methodologies and root cause analysis techniques
• Recognize and escalate critical quality issues appropriately while ensuring timely communication with stakeholders and leadership.
• Utilize electronic quality management systems (eQMS) to manage investigations, CAPAs, effectiveness checks, and associated quality records.

Requirements

• BS/BA in engineering, science, or related field.
• 4-6 years of cGMP experience within biotechnology, biopharmaceutical, pharmaceutical, or other regulated industries, and/or 2-4 years of quality investigation experience. Experience in
  engineering, facilities, equipment, validation, or quality systems is preferred. A combination of relevant industry, technical, and investigation experience will be considered. Demonstrated ability to independently manage multiple concurrent investigations while consistently meeting quality and timeliness expectations.
• Demonstrated proficiency in conducting moderate- to high-complexity investigations, performing risk assessments, identifying root causes, and developing effective corrective and preventive actions (CAPAs).
• Experience conducting product impact assessments and applying risk management principles in support of quality and disposition decisions.
• Experience reviewing and interpreting manufacturing, engineering, maintenance, calibration, environmental monitoring, and validation records to support investigation activities.
• Excellent technical writing and documentation skills, with the ability to independently author clear, concise, scientifically sound, and inspection-ready investigation reports.
• Working knowledge of electronic Quality Management Systems (eQMS)
• Demonstrated ability to effectively collaborate and influence crossfunctional teams in resolving complex quality events.
• Strong Ability to present investigation outcomes and respond to internal audit and regulatory inspection inquiries with minimal oversight.
• Technical knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing processes.
• Proficiency in science- and risk-based decision-making and structured root cause analysis methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Working knowledge of cGMP regulations, quality systems, and data integrity principles.
• Experience supporting regulatory inspections, audits, and health authority inquiries.
• Strong technical writing, communication, and presentation skills.
• Ability to independently manage multiple moderate- to high-complexity investigations.
• Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).

This is a leveled position. Please see the salary ranges for each level below:

Investigator I : $72,791 - $95,540

Investigator II: $78,251 - $102,705

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$72,791-$102,705 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.