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Fluor and Energy Materials, an Orbia business, is looking for a Senior Quality Manager to be based at our Rocksavage and Thornton Science Park offices in the UK.
Occasional travel to customer sites within the UK/Globally expected on the role.
Main Purpose
Overall leadership and management of the pharma/cGMP quality functions for Orbia’s Fluor and Energy Materials business including designated Quality representative at any sites where manufacturing licenses are held. Working closely with the Operations Director and site/business leaders, translate business strategy and goals into strategic and operational plans for the pharma quality functions across various operating locations (and regions), provide visible leadership to the quality teams, collaborate effectively with internal and external customers/stakeholders to ensure delivery of business objectives. This is a senior leadership position with the ability to influence F&EM’s operations and strategy beyond own functional boundaries through efficient delivery of functional objectives, building and sustaining strong partnerships, fostering a learning/continuous improvement culture and creating value whilst always keeping patient safety as a top priority.
Main Responsibilities
Direct leadership and management of the medical quality teams across Fluor and Energy Materials’ UK locations and indirect management of all medical quality aspects across other operating locations with the overall aim of ensuring patient safety, regulatory compliance, world-class service to F&EM’s customers, efficient operations and long-term value-creation for F&EM.
Along with the quality senior management teams, identify, define and implement the requirements of medical quality policies, standards, processes and procedures to achieve and maintain world class performance. To monitor and assess potential future quality and regulatory issues to determine the impact and formulate the most effective strategy for the business.
Through leading by example, ensure that the quality functions across all sites are seen as collaborative partners in serving F&EM’s medical customers. Always promote a culture of quality-beyond-compliance, drive continuous improvement/lean ways of working, a value-mindset and active listening & supporting other stakeholders. Establish, sustain and optimise necessary systems and processes to align, collaborate and communicate with stakeholders.
To develop and maintain functional knowledge and expertise in the medical quality functional areas. To develop the medical quality teams and promote/nurture cross-site or cross-discipline support, communication and collaboration to maximise value and minimise risk for the business.
Keep abreast of F&EM’s strategic plans and by maintaining proactive engagement with business and leadership teams provide necessary insights and support so that not only are quality aspects considered and factored into early thinking re strategic plans but are also delivered seeking optimum value for F&EM’s investments.
Establish and maintain necessary expertise, networks, contacts and processes to monitor and assess any relevant regulatory requirements, risks or opportunities depending upon F&EM’s play to win strategy. Through active involvement and leveraging the team, develop F&EM’s regulatory expertise in the relevant areas as a unique differentiator for the business.
Establish and maintain necessary expertise, resources, systems and tools so that F&EM can leverage the right technological solutions as a world class pharma business. Make strategic and operational choices to maximise value for money, minimise risk and minimise life-cycle costs regarding technology and systems.
Manage the medical quality operational and capital expenditure in line with budgets and business plans.
Qualifications
Graduate in a chemical/scientific discipline.
Knowledge/ Experience Required
Knowledge of pharmaceutical/excipient operations in a highly regulated environment (cGMP).
Technical competence in a broad range of topics e.g. cGxP, regulatory, analytical, laboratory practices, auditing, quality assurance, IT related to quality, change management, deviations, NCs, etc.
Experience in a technical quality or similar function in a pharmaceutical/excipient manufacturing environment (cGMP).
Experience of leading a team of quality professionals is essential.
Excellent communication skills - verbal, written and electronic.
Influencing and rational persuasion skills.
High safety standards, results-orientated, concern for impact and analytical skills.
Knowledge of best practices and latest innovations in IT and data management/integrity will be advantageous.
Experience of being part of multi-discipline leadership or management teams in a manufacturing environment is desirable.
Proven experience with management systems including implementation and auditing (ISO 9001/14001/18001 or 45001) will be advantageous.
Proven experience within Pharma Quality management systems working to UK/EU GMP guidelines (EudraLex Volume 4, Annex 13 and/or IMP 2017/1569) will be advantageous.
Experience of change management, lean/continuous improvement processes, mentoring and developing others will be advantageous.
Behaviours that can help you succeed at Orbia:
Develop yourself & Others
Foster Collaboration & Inclusion
Drive Results
Provide Vision & Direction
We welcome purpose-driven dreamers, doers, and builders, recognizing that it takes difference to make a difference. If you’re ready to bring your skills, talents, and perspective to moving your career, the company, people, and the planet forward, we’d like to hear from you.
We believe that every voice matters; every community deserves respect; and every challenge is an opportunity and united by empathy, we are stronger for our different perspectives. We are dedicated to building a more diverse, inclusive, and equitable workplace that supports the needs of all our employees regardless of their role, location, identity, and background.