Key Responsibilities
• Qualification, monitoring, and management of critical business partners and service providers to ensure regulatory compliance.
• Manage Quality Assurance Agreements (QAA) including creation, maintenance, tracking, and reporting activities.
• Support qualification and onboarding activities for distributors, pharmaceutical wholesalers, and critical service providers.
• Collaborate with cross-functional teams for drafting, reviewing, and maintaining QA agreements.
• Provide oversight and reporting related to QAA status and compliance activities.
• Coordinate with internal stakeholders including Regulatory Affairs, Labelling, Vigilance, Governance, and Quality teams.
• Support internal and external audits, surveillance audits, and compliance inspections.
• Participate in international and cross-functional quality and regulatory projects.
• Support implementation and monitoring of quality assurance mapping measures and corporate compliance initiatives.
• Conduct audits of distributors, suppliers, and service providers after auditor qualification.
• Support identification, implementation, monitoring, and reporting of corporate quality and regulatory processes.
Qualifications & Experience
• Bachelor’s or Master’s degree in Pharmacy, Biology, Chemistry, Life Sciences, or related field.
• Several years of experience in Regulatory Affairs, Quality Management, Quality Assurance, or related areas within Medical Devices or Pharmaceutical industry.
• Strong knowledge of pharmaceutical and medical device regulations and quality management systems including ISO 9001, ISO 13485, GMP, and GDP.
• Auditor qualification or prior experience conducting QMS audits preferred.
• Experience with documentation systems such as Windchill, QTRAK, or similar tools preferred.
• Strong stakeholder management, communication, and collaboration skills.
• Ability to interpret and communicate regulatory requirements effectively.
• Strong organizational skills with structured and detail-oriented approach.
• Very good English communication skills, both written and verbal.
• Willingness to travel as required.
Preferred Skills
• Experience in multinational or global environments.
• Knowledge of supplier/distributor quality processes and compliance frameworks.
• Proficiency in MS Office tools including Word, Excel, and PowerPoint.
• Adaptability, intercultural awareness, and ability to work in cross-functional teams.
