Chemistry, Manufacturing & Control (CMC) Quality Head US
Site Name: USA - Maryland - Rockville
Posted Date: Nov 21 2019
Are you interested in being a part of the Quality for R& D Vaccines organization? The Quality Department is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements. Are you inspired by a role that integrates the fit-for-purpose quality strategy, culture and processes into end-to-end research and development activities for US R&D Site? If so, this Chemistry, Manufacturing & Control (CMC) Quality Head US role could be an ideal opportunity to explore.
In this position, you will be accountable for providing strategic quality input to for US R&D Site, ensuring adequate quality risk management, quality targets, and monitor results in alignment with US R&D Site objectives and to drive end-to-end vision of Vaccines Business in order to lead and coordinate US R&D Site Quality needs to the appropriate Quality Partner within Quality for R&D. You will be required to build a strong Product knowledge related to R&D portfolio within the Quality for R&D organization and lead in a global matrix organization by setting objectives, managing priorities and engaging in business-related/ work process and technology initiatives.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
Strategy and Leadership:
- In alignment with global Quality for R&D strategy and in collaboration with R&D, build agile and fit-for-purpose quality mindset to achieve R&D ambitions on product and projects aligned with GSK strategy
- In alignment with global Quality for R&D strategy and in collaboration with R&D, develop quality culture where every person in the organization takes personal responsibility for the quality of the processes for which they are accountable, supported by fit-for-purpose quality system
- Maintain deep project understanding to support projects on strategic level from quality perspective
- Member of VDT/DPT project teams
- Accountable for the quality on projects assigned to the US R&D site
- Ensure global quality alignment on projects through close interactions with IT and BE counterparts
- Ensure that, for vaccines in development, the product quality strategy is coherent
R&D site and Quality for R&D organization:
- Ensure and drive one voice Quality and efficient connection with global Quality R&D organization
- Ensure local specificities and regulations are integrated in global quality initiatives and processes
- Drive and monitors part of R&D Quality Plan applicable to the R&D US site
- The position will be based in USA - Rockville and requires about 10% of travel.
- Responsible for coaching, motivating USA based Quality teams according to the HPT and modern employer principles
- Drive and monitor adherence to FTE and OPEX targets
- Drive and lead implementation of fit-for-purpose quality mindset in Quality for R&D and R&D organization
- Accountable for delivery of R&D projects quality milestones to achieve and sustain intended business results
- Ensure fit-for-purpose product quality among different projects through alignment with BE and US counterparts and through CMC Quality Leaders
- Quality for R&D representative at VDT and DPT project teams or alternatively delegate to CMC Quality Leader on the specific project
- Build strong project knowledge related to site R&D portfolio within Quality for R&D
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Masters degree/PhD in Sciences or equivalent
- 10+ years of strong management experience in Pharma of Life Sciences industry
- Relevant experience in Quality
- Experience in Research & Development
- Demonstrated strong leadership and problem-solving abilities
- Ability to lead under pressure, implement new initiatives to address business and operational challenges in in a global multi-cultural environment
Preferred Qualifications: If you have the following characteristics it would be a plus:
- Knowledge of GSK Vaccines processes, vaccine environment in terms of R&D and Quality
- Good knowledge of quality and risk management principles and tools
- Ability to lead and influence people in a matrix business environment
- Ability to manage networks and build relationships transversally across GSK Vaccines network
- Strategic thinking and strong drive for implementation
- Executive and leadership capability to manage people
- Excellent communication, presentation and facilitation skills
- Ability to adapt, work under uncertainty and accommodate flexible work demands
- Global perspective; cultural sensitivity
- Ability to withstand pressure; resilient; self-motivated; sense of urgency
- Smart risk-taking mindset
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/Affirmative Action Employer. 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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