Director of Quality Assurance New Berlin, Berlin, Germany

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as aDirector of Quality Assurance?

• Quality SME/Lead responsible maintaining effective Quality oversight and collaboration with project teams and suppliers.
• Ensures all aspects of Quality Management at ISO17025/ISO/15189/GCP/GCLP are conducted according to regulations, local and international regulatory requirements, and Precision for Medicine (PfM) expectations in a phase appropriate approach.
• Develops, implement, and maintain processes and procedures to support quality systems specific to the client interactions; Ensure processes and procedures are adhered to, consistent with health authority regulations, and value-added.
• Regularly collects, reports, and assesses quality KPI’s, metrics, process performance indicators and quality system signals for adequacy of performance to support periodic management reviews.
• Manages and supports the resolution of quality and technical problems identified within PfM in alignment with global standards and ensures that the all-critical and significant issues, which may have an adverse effect on the quality of the study conducted, and data generated to GxP/ISO, are escalated to management, and are resolved within stated timelines.
• Attends cross-functional team meetings and provide guidance to QA staff based on interpretation of current regulations to ensure best practices including risk-based management.
• Identifies quality improvements to PfM Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
• Develops appropriate procedures and process and provides support for method transfer and validation activities to provide QA review and oversight.
• Manages, mentors, and develops direct reports within Quality group.
• Performs, Leads and Manages internal and external audits and regulatory inspections as needed.
• Provides support and contributes to other Quality Assurance activities as assigned.
• Provides inputs to budget, project schedules and QMS performance metrics
• Travel up to 30% including international

Qualifications:

• Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
• > 5 years of supervisory experience in a regulated environment
• 10-12 years’ experience working in a Quality driven life science, regulated environment
• Relevant Industry Certification

Additional Requirements:

• Keen knowledge of QMS, GLCP, ISO13485, ISO 17025 ISO15189, ISO 9001, ICH GCP, EMEA Guidelines
• Experience with Client and regulatory authority audits, Dakks
• Ability to lead and manage a quality team
• Experience in auditing and interacting with regulators, vendors and clients
• Proficient in basic computer applications such as MS Office, Word, Excel, PowerPoint and other relevant industry computerized systems
• Proficiency in written and spoken English and German
• Must possess a valid driver’s license
• Must be able to travel both domestically and internationally

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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