Manager External Analytical Operations
Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence, USA - Pennsylvania - King of Prussia Posted Date: Sep 7 2021 At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers. As a Manager External Analytical Operations, you will be responsible for setting direction and leading the “big picture” relationships with external analytical service providers as well as supporting the individual projects at those providers. The role will work in close partnership with the matrix project workstreams, budget holders, and R&D. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Responsible for analytical supplier performance and delivery in partnership with R&D, PSC, and central functions (e.g., Procurement, Tech) to ensure quality, service, safety, efficiency and cost Direct and support the matrix analytical workstreams (that support MPD and PQTS+ teams) and responsible for day to day management and performance at the analytical suppliers Lead, facilitate and participate in forums/teams that connect teams, stakeholders and partners to deliver all project/analytical workstream objectives e.g., JOCs, APT Coordinate activities in matrix working environment to ensure products tested right first time, meet GSK standards, are delivered to patients on time and are competitively priced to achieve customer satisfaction Build relationships with analytical suppliers to set common objectives and to ensure CMO delivers to GSK standards, supplier maintains compliance with GMP requirements, and risks introduced to GSK network from use of supplier are properly handled and mitigated Support delivery of profit and loss (P&L) targets through effective management of operating and capital expenses, savings contributions, project/product spend, etc. Continuously drive and deliver improvement across service, quality, safety and cost which may include remediation, as needed with analytical suppliers to ensure compliance and viability of products for the long term Manage and proactively evolve the strategic analytical supplier relationships Lead and support assessments necessary to develop analytical sourcing and strategy recommendations (e.g., RFPs, make vs. buy) Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's of Science Degree in Analytical Chemistry, Biology, Biochemistry, or related technical subject area 7+ years of relevant experience in the oversight or management of contract analytical testing Up to 10% travel Preferred Qualifications: If you have the following characteristics, it would be a plus: Coordinates external collaborations with 3rd parties Programmatic decision making skills Able to interact with peers, subordinate and senior personnel in multidisciplinary environment Competency in project management Knowledge of cGMP and regulatory requirements for the development and commercialization of Biopharmaceuticals Familiarity with FDA/EU/ICH regulations and mentorship, particularly as they relate to Analytical Testing Knowledge of method development, technical transfer, validation, stability, release testing, etc. Excellent written/verbal communication, presentation and effective influencing skills. Works well as part of matrix teams Applies technical knowledge to form new insights, anticipates and recognizes potential problems whilst providing workable solutions and can draw sound conclusions based on complex information or expertise from multiple specialty areas 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. 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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