GMP Lead Investigator

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The GMP Lead Investigator is responsible for leading, managing, and documenting investigations related to deviations, nonconformances, complaints, and quality events associated with autoinjector assembly, labeling, and packaging operations performed by SHL Medical Assembly and Services. This role ensures investigations are thorough, compliant, scientifically justified, and executed in alignment with global regulatory requirements and internal quality standards. The GMP Lead Investigator serves as the primary operations representative overseeing all investigation-related activities conducted at SHL Medical Assembly and Services.

Main Responsibilities

• Serve as the lead investigator for GMP deviations, nonconformances, and quality events originating from SHL Medical’s assembly, labeling, and packaging operations
• Conduct structured, science-based root cause analysis (RCA) using approved methodologies (5-Whys, Ishikawa, Fault Tree, etc.).
• Ensure investigations are fully documented, complete, evidence-based, and compliant with internal procedures and applicable regulations.
• Identify true root causes, contributing factors, and systemic gaps impacting product or process performance. Ensure all customer complaints are appropriately documented, investigated to determine root cause, and formally approved.
• Act as the primary contact for all SHL Medical Assembly & Services–led investigations.
• Coordinate with internal functions, such as Quality, Operations, Process Development, Product Development, and Supply Chain, to gather required data, documentation, and process insights.
• Draft and review investigation reports to ensure adequacy, accuracy, and regulatory robustness.
• Ensure on-time investigation closure and effective communication of critical findings to internal stakeholders.
• Perform detailed reviews of batch records, device history records, environmental monitoring reports, equipment logs, in-process testing, and packaging verification data, in support of investigations.
• Assess device-specific risks, including component fit, device assembly controls, labeling accuracy, packaging integrity, and visual inspection outcomes.
• Evaluate historical data, trends, and prior investigations for recurrence or systemic issues.Provide recommendations for product disposition supported by documented risk assessments.
  
  

Skills And Qualification

• 5–7 years of experience in GMP Quality Assurance, Quality Engineering, or Manufacturing.
• Demonstrated experience leading investigations within pharmaceutical, medical devices, or combination product operations.
• Expertise in root cause analysis and CAPA.
• Strong technical writing and analytical communication skills.
• Possesses extensive experience operating within and maintaining compliance with major Quality Management Systems (QMS) and global regulations, including FDA 21 CFR Part 820, ISO 13485, and current Good Manufacturing Practices (cGMP).
• Strong technical expertise in autoinjector assembly, labeling, and packaging.
• Proficient ability to evaluate, interpret, and effectively apply complex compliance requirements and guidelines to real-world, technical situations across the manufacturing and development lifecycles.
• Comprehensive and mandatory knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  
  

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization
  
  

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com