Site Name: GSK HQ, Durham Blackwell Street, Munich, Parma, Tres Cantos, Upper Providence
Posted Date: Jun 25 2024
Audit & Compliance Process Senior Director The role can be located anywhere in the world
The deadline for the job posting is the 15th of July in 2024 We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.
We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Job purpose: The Audit & Compliance Process Director works with the Vice President of Audit & Compliance to transform how we work in the Audit & Compliance teams across global supply chain. This includes managing KPI, leading simplification & standardisation, implementation of quality systems and digital data, leading the global process owner (audit), leading compliance training for auditors, and ensuring compliance to the Quality Management System (QMS)
Key responsibilities: Accountable for developing the strategy and leading the Quality Audit and Compliance (QAC)) process and compliance team to simplify, harmonize and standardize audit and inspection readiness processes where appropriate, including but not limited to processes for requesting new contractor assessments, new audit request forms and/or inspection readiness assessment request forms.
Accountable for leading the QAC process and compliance team members responsible for overseeing the Quality Systems within QAC to deliver the various audit and inspection readiness schedules according to plan and as required, from time to time, by individual Business Development or other projects
Accountable for ensuring that all QAC processes remain QMS compliant and facilitate team delivery of function and supply chain goals.
Accountable for overseeing the development and deployment, under the responsibility of the Audit Global Business Process Owner, of the Global Supply Chain-wide rollout of auditor training, including Self Inspection training, Auditing Essentials training, Auditor Certification Programme training, and other new training packages developed to improve Global Supply Chain (GSC) auditor skills across the GSC Network
Leading the strategy for defining and deploying QAC's departmental KPIs and managing the necessary data sources to generate the defined departmental KPIs and to generate other key business data where required
Leveraging technology to robustly and efficiently trend data from all QAC audit and inspection readiness assessments and activities
Provide routine input into GSC Quality Council and other business meetings on data generated during QAC audits and inspection readiness assessments and the insights drawn from those data
Developing skills and capability to create an agile team that will drive positive business outcomes
Collaborate and partner with QMS to share audit finding trending and that compliance risks are appropriately identified, escalated, and mitigated
Engage with sites across the GSK network to coordinate audits, prioritize support and manage audit risk model
Manage the preparation of the internal and external network annual reports which are provided to the GSC and Quality Leadership teams.
Foster change management culture to facilitate adoption and usage of new ways of working and develop culture of continuous improvement across all audit and inspection readiness activities within the GSC and R&D manufacturing networks
Accountable for motivating the QAC process and compliance team, keeping the team focus and promoting development within the team to ensure the right future ready capabilities and succession plans
Basic Qualifications: BA/BS degree or equivalent in experience (Chemistry, pharmacy, biological sciences, science related)
10 years' experience in Quality function in a highly regulated environment
Demonstrated experience of working at a senior level across various geographical regions and different cultures
Significant experience in strategy development and deployment, change / stakeholder management and business improvement
Demonstrated leadership skills across functions and organisational levels
Significant experience in audit compliance
Proven capacity to drive transformation and manage complex projects and program of projects. Strong in decision-making, problem-solving, and communication.
Excellent influencing and negotiating skills and verbal and written communications skills
Demonstrated ability to operate effectively in a matrix organisation and engage with other business areas
Demonstrated ability to think strategically and identify innovative, sustainable solutions to complex business issues, including leveraging data analytics and AI technologies where available and appropriate
Knowledge and experience in operational excellence / continuous improvement techniques and deployment
Demonstrated people development and performance management skills
Preferred Qualifications: If you have the following characteristics, it would be a plus:
Masters Degree
Strong background in QC and QA systems and/or operations
Technical understanding of pharmaceutical manufacture and quality standards in a complex and scientific industry
*LI-GSK
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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