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