Senior QA Specialist

Overview

We are seeking an experienced Senior QA Specialist to join the Site Quality team supporting biologics manufacturing operations. This role will focus on Quality Management Systems (QMS), document control, archival strategy, and continuous improvement initiatives, ensuring compliance with cGMP standards and regulatory requirements across site activities.

Key Responsibilities

• Manage and maintain site Quality Management Systems (QMS) to ensure compliance with cGMP and internal quality standards

• Lead and support document control activities, including review, approval, and lifecycle management of GMP documentation

• Develop, implement, and optimize document archival strategies and systems (physical and electronic) to ensure data integrity, traceability, and regulatory compliance

• Author, review, and update Standard Operating Procedures (SOPs) and quality documentation in alignment with site and global standards

• Support and manage change control processes, ensuring timely assessment, impact evaluation, and closure in line with quality requirements

• Drive continuous improvement initiatives across site quality systems, identifying gaps and implementing process enhancements

• Ensure compliance with data integrity principles (ALCOA+) and support inspection readiness activities

• Collaborate cross-functionally with Manufacturing, Engineering, Validation, and QC teams to ensure alignment of quality processes with operational needs

• Support internal and external audits and regulatory inspections, including preparation, documentation review, and response to observations

• Provide guidance and mentorship to junior QA staff on QMS processes and best practices

Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related discipline

• Minimum 5 years of experience in Quality Assurance within biopharmaceutical / biologics manufacturing environments

• Strong hands-on experience in QMS, document control, SOP authoring, change control, and archival/document management systems

• Good understanding of cGMP regulations (FDA, EMA, PIC/S) and data integrity requirements

• Experience supporting regulatory inspections and audit readiness

• Familiarity with electronic document management systems (e.g., Veeva, TrackWise, MasterControl, etc.) is an advantage

• Strong stakeholder management and communication skills in cross-functional environments