Job purpose:

As Quality Compliance Director SPQ you,

• Provide leadership and direction to ensure the Strategic Product Quality organization operates in compliance with GSK standards

• Lead Quality performance and compliance for the operational business unit, monitor KPI Performance and initiate action as required

• Ensure incidents are appropriately escalated, managed, and communicated to the authorities

• Provide support in assessing the impact of critical deviations

• Ensure the Quality risks for the business unit products are identified understood and managed and that the Quality Risk Model is used to effectively identify and manage risk

• Act as the Business process owner interface for quality systems and processes, partnering with quality leaders across global teams.

Your responsibilities:

• Support the implementation of the quality strategy for the business unit network

• Contribute to quality performance and culture ensuring adverse trends in compliance dashboards are investigated and action taken.  Support site inspections as required

• Oversight/ Chair for PIRC and LIC process ensuring incidents are properly escalated and managed and support key quality decisions

• Local Business Owner for enterprise quality management systems, acting as a key interface between SPQ, R&D and Quality Systems and Data organization

• Accountable for the T1/T2 Quality Council process for SPQ and Regulatory Compliance, ensuring agenda and escalation are appropriate to drive improvement and mitigate risks. Ensure that QC process is continuously improved

• Accountable for the Quality Performance meeting ensuring that all the quality metrics are understood, trend identified and resolved, and status of compliance improved, including leading Quarterly Deviation Trend review and coordinating regional CAPAs and actions (as an example A&A audit has CAPAs which is applicable to all PSM Sites)

• Support teams in effectively deploying the GSK Quality Management System (QMS) and own the quality and compliance governance processes required by the QMS, e.g. Quality Council, Risk Management, Quality Risk Model and LIC/PIRC processes

• Accountable for the risk trending and oversight, Gemba and ensures that SPQ teams progress action plans

• Communicate with other functions and provide Regional inputs (Inputs to draft Quality Alert, Monthly PRS Meeting, Monthly QMS Tier1, etc.).

Additional information:

• Reporting line: VP Strategic Product Quality

• Number of positions available: 1

• People management (direct/indirect reports, etc.): no

• Business travel requirements: less than 10%

• Primary location: Wavre, Belgium

• Secondary location: Europe, UK, US. Applicants located close to strategic vaccines manufacturing locations will be considered on a case-by-case basis. No relocation support provided.

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Minimum BA/BS degree level in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines

• Minimum 10 years of experience in Quality in a highly regulated environment

• Experience in Product Quality and Compliance

• Knowledge of cGMP globally

• Knowledge of CEP products

• Knowledge and application of the QMS

• Knowledge of OE tools and KPI management

• Ability to influence teams and to drive change

• Ability to standardize and work across boundaries

• Fluency in English both written and spoken

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master’s degree level or higher in Biological Sciences, Chemistry, Pharmacy or related scientific disciplines

• Business Management degree e.g. MBA

Application closing date: Friday October 25th, 2024 EOD.

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.

 
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