GMP QA Compliance Specialist

Supports and maintains the site Quality Management System (QMS) by ensuring local procedures align with the company’s Group Quality Standards and applicable GMP regulations. Leads structured gap assessments, identifies and drives remediation activities, coordinates implementation of required changes, and partners with Global Quality and cross-functional stakeholders to sustain compliance and continuous improvement.

Responsibilities

• Lead gap assessments of local QMS procedures against Group Quality Procedures and Corporate Standards.
• Coordinate updates to local SOPs, work instructions, and controlled documents.
• Track implementation and drive completion to defined timelines; escalate risks as needed.
• Partner with process owners and SMEs to establish and implement compliant solutions.
• Support Change Control, CAPA, Deviations, and Quality Risk Management activities.
• Support internal audits and regulatory inspections; assist in remediation and follow-up.
• Monitor compliance metrics and prepare management reports using trending and visual KPI management.
• Develop and deliver training and guidance on new or revised quality procedures.
• Drive continuous improvement and harmonization of quality system processes.

Requirements

• Bachelor’s degree in life sciences or equivalent experience (required).
• Master’s degree or equivalent experience in business, engineering, or related field (preferred).
• 3–5 years in quality assurance or GMP environment (0–3 years in CGT manufacturing acceptable).
• Relevant quality or GMP certifications (a plus).

Skills

• Knowledge of cGMP and applicable regulations.
• Experience with Change Control, CAPA, deviations, audits, and risk management.
• Project management skills: presentations, stakeholder liaison, meeting facilitation.
• Familiarity with Trackwise, SAP, and document management systems (preferred).
• Strong planning, organizing, and decision-making abilities; detail oriented.
• Ability to manage multiple priorities and meet tight timelines under pressure.
• Self-motivated, good written and verbal communication, team player, customer focused.
• Demonstrates agility, business acumen, collaboration, drive for results, and leadership accountability.

Working Conditions

• Work schedule: regular office hours.
• Environment: office setting; may require occasional site presence and gowning.
• Physical: primarily office/admin tasks; occasional standing, walking, bending; occasional lifting up to 50 lbs.
• Safety: must follow job safety procedures, attend required training, and promote safety.
• Mental demands: frequent stakeholder interaction, analytical and critical thinking required.

Pay

The hiring range for this position is $69 to $79.58 per hour. The base pay actually offered will take into account internal equity and may vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.