Distributor Management at Fresenius… · Bengaluru

Distributor Management Location: Bengaluru, KA 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.