Stability Manager

Site Name: USA - Pennsylvania - King of Prussia, Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Jan 28 2022 The ALM Stability Manager is a strategic role and has the responsibility and accountability for ensuring that the product stability programs for biopharmaceutical products at PSC Upper Merion Biopharm site and contract partners are successfully designed, implemented, and executed to support product shelf-life for non-clinical use, clinical use and commercial distribution. The Stability Manager administers the compliance of the group in reference to regulations, guidelines, procedures, and practices governing GMP stability. Responsible for strategy deployment of the stability programs. Other functions: reviews and approves, stability reports, technical reports; and authors and reviews stability modules for use in regulatory submissions (IND, IMPD, BLA, MAA). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Provides leadership, manages performance of Stability Leads, develops performance plans, accurately assesses development needs to establish development plans in helping achieve objectives and enhancing performance and career advancement; coaches staff to achieve their full potential; leads and motivates staff to achieve individual and business goals Responsible for setting stability/ALM strategies and implementation of stability work processes in line with regulatory and business requirements Manages / oversees external contract organizations with respect to stability testing / reporting Review and approval of stability protocols and reports with oversight of regulatory data within the relevant CMC sections Responsible for GMP compliance in ALM Stability—specifically, oversees stability OOT/OOS and quality incident investigations and troubleshooting activities Support batch release including approving of certificates of analysis Interfaces with customers to assure customer satisfaction and accomplishment of group objectives Participates in BioPPD / MPD teams as ALM representative Interface with other groups (incl. BPS, RA, UMBL) on project related stability issues Participate in, and conduct GMP audits, PAIs, and due diligence as needed Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree 7+ Years in Pharmaceutical stability program Management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: 3+ Years Bio-Pharmaceutical stability program Management Strong experience with GMP stability program management in industry that supports both clinical and commercial biopharmaceutical products, with specific experience in writing regulatory submissions (IND,IMPD, BLA, MAA) and supporting regulatory inspections. Strong understanding of Statistical analysis as it pertains to stability data trending and product shelf life application. Strong verbal and written communication skills. Demonstrated supervisory and leadership skills. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including biopharm development, QC, and QAFully versed in GMPs, ICH Guidelines, FDA, and other regulatory agency requirements for stability. 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. 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