Associate Director, UM Tissue Bank
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Sep 28 2021 The Associate Director, Tissue Bank is responsible for all activities related to the daily operation of the tissue bank including, but not limited to, overall supervision tissue sample receipt, inspection, accessioning, archiving and compliance. Associate Director, Tissue Bank will also be responsible for the execution of all employee training and qualification, as well as for the maintenance of compliance of the bank's activities with applicable local, state, federal regulations and standards. This position requires the combined understanding of facility operations and management, regulatory compliance, and clinical biological sample management and testing in order to be able to provide operational oversight of a GxP-compliant human tissue biobank. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for the day to day operation of the Upper Merion, PA Tissue Bank and direct supervision of staff archivists. Participates in all aspects of planning, receipt, accession, preparation, preservation, identification, documentation, storage, and distribution of clinical samples. Develops and maintains protocols for clinical sample intake, inspection, registration, quality control, archiving and retrieval. Ensures compliance with applicable standards and best practices around clinical biological sample storage and re-use, such as GDPR, 21CFR, HIPAA, GxPs, Common Rule, and HTA. Oversee and assist with all tasks related to clinical sample banking including recovery, labelling, packaging, and shipping. Assist all UM Tissue Bank staff as necessary. Responsible for the development, implementation, execution, and monitoring of department orientation and annual training for Tissue Bank staff. Assists in monitoring and coordinating performance improvement activities, including corrective actions, as they relate to all tissue bank activities with a constant goal of identifying opportunities to strengthen the existing program. Acts as the point of contact for clinical trial specimen manager for the coordination of clinical sample shipping and archiving. Ensure the maintenance and quality control of the electronic patient and sample data files, as well as, department records and reports, to ensure accuracy, completeness, and compliance. Note: this position is required to participate in a 24/7 on-call rotation for responding to temperature excursions and/or equipment failures. Perform other duties as assigned. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Master's Degree (MS) in Bioinformatics, or equivalent degree in Molecular Biology, Genetics, or another Biological Science. Eight years (8) or more experience in clinical testing, biobanking, data management, and/or bioinformatics, or related field. LIMS experience - working experience with specialized data for sample management. People Management experience. Knowledge of clinical biobanking best practices and requirements (GxPs, UK Human Tissue Act, EU GDPR, CAP BAP, ISBER, New York State requirements for clinical specimen archiving). Preferred Qualifications If you have the following characteristics, it would be a plus: PhD in Bioinformatics or equivalent degree in Molecular Biology, Genetics, or another Biological Science. BB(ASCP), HTL(ASCP), MB(ASCP), MLS(ASCP), 6Sigma Black Belt. Direct Clinical Trial experience. Strong working knowledge of biobanking best practices and GxPs. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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