R&D Quality Manager

Brunel; Tirol; Hybrid; EUR 62.000 - 90.000; Vollzeit

Zusammenfassung

Brunel is seeking an experienced R&D Quality Manager to lead compliance in a pharmaceutical R&D environment. You will ensure adherence to GxP, support Health Authority inspections, and drive CAPA and deviation processes across cross-functional teams.

The role offers involvement in international quality initiatives and long-term career growth in a highly regulated industry, with flexible home-office options depending on project requirements.

Qualifikationen

• Degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or similar.
• Several years of experience in Quality Assurance or Compliance.
• Strong knowledge of GxP regulations and quality requirements.
• Experience with Deviations, CAPA and Root Cause Analysis.
• Audit and inspection experience is an advantage.
• Experience reviewing quality-related documentation.
• Background in Pharma, Biotech or Life Sciences.
• Strong quality and compliance mindset.
• Structured and analytical way of working.
• Excellent communication and coordination skills.
• Fluent English, German is a plus.

Aufgaben

• Support the creation and maintenance of regulatory and quality-related documentation
• Assist in the preparation and coordination of Health Authority inspections and audits
• Contribute to Quality Plans and quality-related project activities
• Manage and support deviations, CAPA activities, and root cause investigations
• Monitor the implementation and documentation of corrective and preventive actions
• Review and approve quality-related documents, processes, and deliverables
• Identify opportunities for continuous improvement within quality and compliance processes
• Support quality-related activities involving IT systems, equipment, and external partners
• Collaborate with cross-functional teams and clinical development programs
• Ensure compliance with GxP requirements and internal quality standards

Kenntnisse

Quality Assurance

Regulatory Compliance

GxP Knowledge

Deviations CAPA RCA

Audit & Inspection

Documentation Review

Pharma/Life Sciences

Communication Skills

English Fluency

German Helpful

Ausbildung

Degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or similar

Jobbeschreibung

To strengthen our team, we are looking for an experienced R&D Quality Manager (m/f/d) for a challenging project within a pharmaceutical research and development environment. In this role, you will be responsible for ensuring compliance with regulatory requirements, internal quality standards, and applicable GxP guidelines while working closely with Quality, Development, Compliance, and other internal and external stakeholders.

Key Responsibilities

• Support the creation and maintenance of regulatory and quality-related documentation
• Assist in the preparation and coordination of Health Authority inspections and audits
• Contribute to Quality Plans and quality-related project activities
• Manage and support deviations, CAPA activities, and root cause investigations
• Monitor the implementation and documentation of corrective and preventive actions
• Review and approve quality-related documents, processes, and deliverables
• Identify opportunities for continuous improvement within quality and compliance processes
• Support quality-related activities involving IT systems, equipment, and external partners
• Collaborate with cross-functional teams and clinical development programs
• Ensure compliance with GxP requirements and internal quality standards

Qualifications & Skills

• Degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or similar
• Several years of experience in Quality Assurance or Compliance
• Strong knowledge of GxP regulations and quality requirements
• Experience with Deviations, CAPA and Root Cause Analysis
• Audit and inspection experience is an advantage
• Experience reviewing quality-related documentation
• Background in Pharma, Biotech or Life Sciences
• Strong quality and compliance mindset
• Structured and analytical way of working
• Excellent communication and coordination skills
• Fluent English, German is a plus

What We Offer

• Opportunity to work in a highly regulated pharmaceutical R&D environment
• Involvement in international and cross-functional quality initiatives
• Challenging projects with leading Life Sciences organizations
• Flexible home office options depending on project requirements
• Long-term career opportunities within an innovative and growing industry
• Annual gross salary starting from €62,000
• Willingness to overpay depending on qualifications and experience