Pharmacologist - Quality Assurance Management, NGS (m/f/d)

Beschreibung

Quality Assurance Manager (m/w/d)



PENZBERG, GERMANY

Foundation Medicine is leading a transformation in cancer care, where each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease. As a molecular information company, we are focused on fundamentally changing the way in which patients with cancer are treated. Our products provide more than information. They offer hope to patients, their families and friends, their physicians and caregivers. Foundation Medicine promotes a diverse, fast-paced and team-oriented environment, integrating laboratory science, cancer genetics and genomics, process data metrics and clinical data.

As a member of the Foundation Medicine team you’ll work with everyone fighting the disease patients and their families, payers, physicians, drug developers to raise awareness about this transformation in cancer care and Foundation Medicine’s role to ensure we’re delivering the tools and information they need to make an impact and drive access for patients everywhere. Foundation Medicine is headquartered in the heart of Cambridge, MA. Since October 2017, Foundation Medicine GmbH in Penzberg has been actively

Your Team

Foundation Medicine is seeking to add a Quality Assurance Manager, preferably in the field of Next Generation Sequencing (NGS), to its rapidly growing team in Penzberg, Germany. The role is based within the Foundation Medicine GmbH Team in Penzberg, which currently consists of approx. 70 employees in various roles. We continue to maintain our startup mentality and strong team spirit, which is reflected in short decision paths, mutual support, and high levels of trust. For over three years, we here in Penzberg have been making a genuine contribution to the lives of many patients around the world-to ensure we can continue to do so, we need you in our team! supporting this mission.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.

Your 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.
• Well organized.
• Excellent communication skills.
• Familiarity with Laboratory Information Management System (LIMS).

Development opportunities and benefits

• You can expect a high degree of independence and a flexible working environment
• (work from home/office)
• We stand for sincere and trust-based interaction with each other
• Your personal and professional development is very important to us
• All the advantages of a familiar work environment while being embedded in a large, global company