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.
