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Associate Director - Quality, Oncology EMU, Waltham, MA

Waltham, Massachusetts; Collegeville, Pennsylvania
Closing date
Dec 6, 2021

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Life Sciences, Oncology
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Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Nov 4 2021 Oncology is a core area of intensive focus at GSK, and while much progress has been made in the past few years, more can be done to REDEFINE EXPECTATIONS in cancer care. As we look to redefine expectations in oncology, we need experienced, entrepreneurial-minded leaders to help us on this journey. The Experimental Medicine Unit (EMU) Quality team is seeking an Associate Director - Quality, Oncology EMU. The EMU is responsible for biomarker and diagnostic activities within Oncology R&D at GSK. This position will support the development and oversight of a fit-for-purpose Quality Management System for the EMU, ensuring that policies, procedures and systems are implemented in alignment with Global GSK quality standards and applicable regulatory requirements. Key responsibilities include: Support the development and oversight of a fit-for-purpose Quality System for the Oncology Experimental Medicine Unit (EMU) Manage the development of site-level SOPs, Work Instructions, Guidance Documents, other controlled documents in harmonization with the GSK Quality System. Oversight of the EMU Issue Management process to ensure quality related issues are reported, assessed, resolved, and/or escalated in a timely manner Support the internal audit program for critical EMU processes including third party oversight, biomarker assay validation, etc. Support audit and inspection readiness activities Manage site-level department training curricula and generate training compliance reports Develop, monitor and report Quality metrics for EMU activities including clinical trial specimen management, clinical biomarker/diagnostic testing, external partner Key Performance Indicators (KPI's), sample bank, etc. Perform gap assessments to identify compliance risks and opportunities for improvement; communicate and remediate gaps Support Enterprise-wide quality and risk management workstreams Other duties, as required Why you? Basic Qualifications: BS/MS/PhD degree in Engineering, Life Sciences or equivalent experience required 7+ years in Quality, Compliance or equivalent experience in a regulated setting required (i.e. Pharma, Biotech, IVD, Medical Device, etc.) Preferred Qualifications: Experience managing Quality Systems / Processes preferred Experience with biomarker and diagnostic assay development in drug clinical trials highly desirable Knowledge / experience with global and local quality standards and regulations highly desirable: 21 CFR Part 820 Good Clinical Practice (GCP) CAP / CLIA In Vitro Diagnostic Regulation (IVDR) ISO 15189 ISO 13485 Why GSK? As GSK Focuses on Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities 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. Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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