Director of Quality Assurance
Director of Quality Assurance
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Job Description
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 stagesfrom early development through approvalwith 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. Wont you join us today as aDirector of Quality Assurance
Essential Duties & Responsibilities
- 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 KPIs 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:
Minimum Requirements:
- Bachelors 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 drivers license
- Must be able to travel both domestically and internationally
Any data provided as a part of this application will be stored in accordance with ourPrivacy CA applicants please also refer to ourCA Privacy Notice.
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.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying you may contact Precision Medicine Group at .
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team hiring managers and a formal interview process.
Required Experience:
Director
Employment Type
Full Time
