How you match
01Skills
02CommunicationQuality assurancecGMPrisk assessmentsCollaborationProject management softwareStakeholder engagementMedical device developmentRegulatory Compliance in MedicinePharmaceutical Sales
The role
03Your tasks:
- Lead and support global TRD project teams on quality-related topics, questions and issues
- Develop project quality strategies in alignment with TRD and cross-functional stakeholders
- Provide quality oversight for assigned development projects, including scientific and technical guidance
- Prepare and guide project teams for Mock-PAI, PAI and submission readiness activities
- Support quality agreements, contract input and amendments with third parties
- Contribute to global and cross-functional initiatives, including risk assessments and contingency planning
01Lead and support global TRD project teams on quality-related topics, questions and issues
02Develop project quality strategies in alignment with TRD and cross-functional stakeholders
03Provide quality oversight for assigned development projects, including scientific and technical guidance
04Prepare and guide project teams for Mock-PAI, PAI and submission readiness activities
05Support quality agreements, contract input and amendments with third parties
06Contribute to global and cross-functional initiatives, including risk assessments and contingency planning
Requirements
↳Proven experience in pharma quality, operations, quality assurance or quality control
↳Strong background in medical devices or combination products, ideally over several years
↳Knowledge of quality standards, cGMP requirements and regulatory expectations for submissions and inspections
↳Experience with Health Authority inspections, including FDA and EMA, and Notified Body inspections
↳Ability to work effectively in matrix teams and support strategic project delivery
Benefits
Company
04RGRM Group AG
Pharmaceuticals
