The Role
Leads product quality complaint investigations from initiation through closure, conducting root cause analysis, assessing product impact, managing CAPAs, and ensuring GMP compliance. Collaborates cross-functionally with manufacturing, suppliers, quality control, engineering, and supply chain teams. Identifies continuous improvement opportunities within the quality management system and manages multiple investigations according to established timelines and regulatory expectations.
Summary Generated by Built In
Key Responsibilities
- Lead, conduct and document Product Quality Complaint investigations from initiation through closure.
- Perform root cause analysis using structured investigation tools and methodologies.
- Assess product impact and support risk evaluations.
- Develop, implement, and track CAPAs to completion.
- Collaborate with Manufacturing, Suppliers, Quality Control, Engineering, Supply Chain, and other functions to gather information and drive investigation outcomes.
- Ensure investigations are completed in accordance with GMP requirements, company procedures, and established timelines.
- Identify and recommend continuous improvement opportunities within the Quality Management System.
Qualifications & Experience
- Bachelor's degree in scientific discipline such as Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related field.
- Minimum 3 years of investigation experience within a GMP pharmaceutical or biotechnology environment.
- Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations.
- Strong understanding of cGMPs, quality systems, and regulatory expectations.
- Proficiency in root cause analysis and risk assessment methodologies.
- Excellent written communication, analytical, and problem-solving skills.
- Ability to manage multiple investigations and work effectively in a cross-functional environment.
Skills Required
- Bachelor’s degree in Chemistry, Microbiology, Pharmacy, Biochemistry, Engineering, or a related scientific discipline
- Minimum 3 years of investigation experience in a GMP pharmaceutical or biotechnology environment
- Experience conducting Product Quality Complaint, deviation, OOS, and CAPA investigations
- Strong understanding of cGMPs, quality systems, and regulatory expectations
- Proficiency in root cause analysis and risk assessment methodologies
- Excellent written communication, analytical, and problem-solving skills
- Ability to manage multiple investigations and work effectively in a cross-functional environment
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
