Company
DistributorManagement
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Distributor Management. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. 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.”
What You'll Achieve.
ensure regulatory compliance; reporting activities; oversight and reporting related to QAA status and compliance activities; Support implementation and monitoring of quality assurance mapping measures and corporate compliance initiatives; Support identification, implementation, monitoring, and reporting of corporate quality and regulatory processes
Industry & Context.
Willingness to travel as required.
What They're Looking For.
Must Have
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., knowledge of pharmaceutical and medical device regulations and quality management systems including ISO 9001, ISO 13485, GMP, and GDP., Ability to interpret and communicate regulatory requirements effectively., organizational skills with structured and detail-oriented approach., Very good English communication skills, both written and verbal., Willingness to travel as required.
Nice to Have
Auditor qualification or prior experience conducting QMS audits preferred., Experience with documentation systems such as Windchill, QTRAK, or similar tools preferred., stakeholder management, communication, and collaboration 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.
What You'll Do.
and management of critical business partners and service providers to ensure regulatory compliance.
Manage Quality Assurance Agreements (QAA) including creation
and reporting activities.
Support qualification and onboarding activities for distributors
pharmaceutical wholesalers
and critical service providers.
Provide oversight and reporting related to QAA status and compliance activities.
Support internal and external 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
and service providers after auditor qualification.
Support identification
and reporting of corporate quality and regulatory processes.
How You'll Work.
Team & Collaboration
Collaborate with cross-functional teams for drafting, reviewing, and maintaining QA agreements.; Coordinate with internal stakeholders including Regulatory Affairs, Labelling, Vigilance, Governance, and Quality teams.; Participate in international and cross-functional quality and regulatory projects.; ability to work in cross-functional teams.
Communication Scope
stakeholder management, communication, and collaboration skills.; Ability to interpret and communicate regulatory requirements effectively.; Very good English communication skills, both written and verbal.
Full Job Description
**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 structure
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