Senior QS Specialist

About the role

We are seeking an experienced Senior QS Specialist to take a leading role in maintaining and improving our Quality Management System. You will drive quality initiatives, lead change control activities, ensure GMP compliance, support regulatory inspections, and contribute to the development of a quality culture across the organization.

Key responsibilities

• Lead and manage the Change Control system from initiation through closure.
• Ensure timely execution and follow‑up of quality‑related actions, CAPAs, deviations and compliance initiatives.
• Monitor project progress, quality risks and issue resolution activities.
• Facilitate communication between internal teams and external stakeholders.
• Review and contribute to project schedules, validation activities and risk assessments.
• Escalate quality risks and critical compliance issues to management.
• Prepare, review and maintain GMP‑compliant documentation and procedures.
• Lead or coordinate internal audits and support external regulatory inspections.
• Drive continuous improvement initiatives within Quality Systems.
• Mentor junior QS team members and participate in supplier qualification and quality risk management.

Required profile

• Master’s degree in Biotechnology, Bioengineering, Biology, Biochemistry, Microbiology, Chemistry, Pharmacy or a related field.
• At least 3 years of experience in Quality Assurance or Quality Systems within a GMP‑regulated environment.
• Strong knowledge of GMP requirements and Quality Management Systems.
• Fluency in Lithuanian and English.

Required skills

• Experience managing Change Control, CAPA, deviations and audit activities.
• Proficiency with MasterControl or other eQMS platforms.
• Advanced computer literacy and strong skills in Microsoft Office applications.