About the Job

The Manager, Quality Assurance is responsible for overseeing quality deliverables in area of assignment and expertise maintaining a competitive advantage for FMI. This position supports the execution of the planning and work of multiple projects with a big picture mindset and is accountable for achieving all related business goals.

Key Responsibilities

• Perform and manage internal audits and external audits by regulatory authorities and pharmaceutical companies.
• Perform external supplier and vendor audits (international and domestic).
• Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
• Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.
• Generate and report required Quality Metrics and data for Management Review to meet regulatory requirements.
• Subject matter expert and strategist for project-related questions within the subject matter area and beyond.
• Maintenance, surveillance, and continual improvement of an ISO 15189 and 13485 compliant Quality Management System (QMS).
• Complete training on additional Foundation Medicine QMS elements to act as competent back-up.

Qualifications

• Scientific Academic degree or similar.
• Formal training as auditor by a recognized organization.
•  Multi-year working experience in a relating field; preferably in the regulated pharmaceutical, biotechnology or diagnostic industries.
• Strong regulatory compliance knowledge including applicable GCP, ISO standards, as well as CLIA, CAP and FDA QSR knowledge. Scientific background in molecular biology and/or NGS.
• Experience with managing QA activities across multiple quality system requirements (e.g., operating under both ISO 15189/13485/17025 standard and FDA part 820 regulations).
• Able to communicate professionally across a variety of stakeholders to support internal and external audits of commercial partners or suppliers.
• Must be detail oriented with excellent prioritization and organizational skills.
• Superior analytical and problem-solving skills.
• Must be able to provide results on schedule in a fast-paced, dynamic environment.
• Track record in working in an international environment and fluency in spoken and written German and English.
• Proficiency utilizing Microsoft Office Suite, specifically Excel and PowerPoint.
• Excellent communication skills.
• Familiarity with Laboratory Information Management System (LIMS).
• Fluent in GERMAN and ENGLISH