Maintain and improve the quality management system.
Ensure compliance with global policies, regulations, and industry practices.
Administer TrackWise and SLMS (iComply) systems, manage user training.
Oversee document control and Documentum system user management.
Manage Deviation and CAPA systems, review and approve problem reports.
Handle product complaints and recalls as needed.
Manage GxP-related changes and mitigate risks.
Coordinate self-inspections and follow up on actions.
Assist in audits and follow up on audit responses.
Improve review and approval processes for production batch records.
Oversee QA release of finished products in GPMS.
Manage validation/qualification systems, review protocols and reports.
Oversee cold chain management and facility conditions.
Evaluate suppliers and maintain the Approved Supplier List.
Improve processes for Incoming Inspection and packaging checks.
Lead quality system and operational quality functions.
Perform additional duties as requested.
Knowledge, Skills, Abilities:

Education: Bachelor’s degree in life sciences, chemistry, pharmaceuticals, or related field.
Experience: Over 5 years in quality assurance/control; pharmaceutical experience preferred.
Knowledge: Strong understanding of quality management, GxP, clinical trial materials; supply chain or warehouse knowledge is a plus.
Competency: Excellent communication, problem-solving, decision-making, attention to detail, and leadership skills; proficient in English.