The Quality and Regulatory Services Senior Auditor position works with internal staff, Network partners, and Be The Match BioTherapies (BTMBT) clients to assess and improve compliance of operational processes and systems, in support of NMDP’s strategic objectives. This role assures continuing compliance with cellular therapy regulations and promotes the highest standards of safety for donors, patients and products. Primary compliance accountabilities include oversight of the QRS Audit Program for NMDP core business and new business development, participation in the AC qualification process and active engagement in strategic planning regarding the audit process.
• Advanced applied knowledge of auditing principles and practices in an FDA regulated industry such as biologics, blood, tissues, pharmaceutical or medical device.
• Knowledge of Good Manufacturing Practices (GMP) required and Good Tissue Practices (GTP) desired.
• Knowledge of contract manufacturing principles and practices desired.
• Think analytically and critically; communicate and collaborate with internal stakeholders and with external partners and clients.
• Demonstrate strong technical writing skills.
• Meet deadlines and manage multiple tasks and projects simultaneously.
• Actively engage in strategic planning regarding audit process.
• Demonstrate proficiency with Microsoft Office applications.
• Exhibit strong interpersonal skills.
• Work independently and as part of a team.
• Commit to overnight travel of approximately 2-4 trips per month.
Education and/or Experience:
• Bachelor’s degree in medical technology, biology, biotechnology or other health-science related field. Auditor certification required.
• Seven years of experience as an auditor in an FDA-regulated industry such as biologics, blood, tissues, pharmaceutical or medical device.
Be The Match®, operated by the National Marrow Donor Program®, provides hope for a cure to life-threatening blood cancers and diseases. We connect patients with their donor match for a life-saving blood stem cell transplant. We support patients through the transplant process, educate health care professionals, and conduct innovative research. Be The Match provides challenging, meaningful opportunities in support of employee growth and development for about 1,000 people throughout the U.S. Named Star Tribune’s Top 150 Workplaces in Minnesota for the fifth year in a row, we are driven by our mission, value diversity, embrace learning, and live our core values.
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