Senior QA Project Lead - Medical Devices & Combinations

K-Recruiting GmbH; Lavamünd; Vor Ort; EUR 148.000 - 191.000; Vollzeit

Zusammenfassung

K-Recruiting GmbH is seeking a Senior Quality Assurance Project Manager for Medical Devices and Combination Products to lead global QA activities. The role focuses on strong quality guidance, regulatory interactions, and cross-functional collaboration within TRD and external partners.

The position requires a PhD-level focus on quality with extensive experience in drug and device development, regulatory inspections (FDA/EMA) and Notified Body processes. Basel-based, on-site, 5 days/week.

Qualifikationen

• Bachelor degree with 10 years pharma experience.
• Master degree with 5 years pharma experience.
• Business fluent English.
• Experience in medical device/combination product QA.
• Knowledge of QA standards and policies in drug and medical device manufacturing.
• Experience with FDA/EMA inspections.
• Notified Body inspections and RegCMC knowledge.
• Experience with health authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs).
• Broad experience in combination product development and QA/QC.

Aufgaben

• Lead and support global TRD QA teams and represent QA at meetings.
• Ensure quality oversight on development projects per cgmp and procedures.
• Contribute to project strategy, contingency planning, and risk assessments.
• Ensure alignment with TRD QA strategies and governance.
• Coordinate interactions between TRD QA and other departments.
• Communicate project strategy and issues to management and stakeholders.
• Provide input to QA contracts and third-party agreements.
• Prepare Mock-PAI and PAI for submissions.
• Ensure timely, high-quality project documentation and updates.
• Provide reliable communication on project issues to TRD leadership.

Kenntnisse

English (business fluent)

FDA inspections

Notified Body inspections

RegCMC knowledge

HA submissions (INDs/IMPDs/NDAs/ANDAs/

Combination product QA

Cross-functional teams

Quality Oversight

Ausbildung

Bachelor degree +10 years pharma experience

Master degree +5 years pharma experience

Jobbeschreibung

K-Recruiting GmbH is seeking a Senior Quality Assurance Project Manager for Medical Devices and Combination Products to lead global QA activities. The role focuses on strong quality guidance, regulatory interactions, and cross-functional collaboration within TRD and external partners.

The position requires a PhD-level focus on quality with extensive experience in drug and device development, regulatory inspections (FDA/EMA) and Notified Body processes. Basel-based, on-site, 5 days/week.