Senior Manager, Third Party Clinical Labs Quality

il y a 1 semaine

Rixensart, Belgique GSK Temps plein

**_Be You’ at GSK_**

At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to **our values. These **are at the heart of everything we do and include**:Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.**

**When you set out on your adventure at GSK, we make a deal. **You commit to living our values and expectations and performing against our **Innovation, Performance and Trust **priorities. In return, GSK commits to providing the **right environment for you to thrive. **Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a, we empower you to be yourself, share ideas and work collaboratively

Senior Manager, Third Party Clinical Labs Quality

**In this role you will **

1. Drive and support the business in implementing the end-to-end quality oversight of a portfolio of approximately 100 third parties in scope:

- Make the initial assessment of external providers utilizing Quality Questionnaires/Self-assessment, assess third parties (gap analysis) and drive decision-making with remediation plan and level of audit/assessment required (quality risk management)
- Lead, negotiate, review and implement Quality Clauses/Agreements with business partners and third parties in scope and/or across R&D, including GSK Pharma for vendors in common, in order to ensure compliance to current regulations, GSK quality standards associated with the activities to be carried out by the third party.
- As relevant, allow that all information/documentation (procedures - submission documentation ) is transferred to the external provider, and act as a trainer if requested by the R&D Business Owner
- Ensure that the vendor qualification is completed before the contract becomes effective
- Risk Management: Support and assist in risk areas identification, escalation and mitigation plan development. Evaluate, follow up, trend, give feedback and/or approve the deviations generated during activities according to the quality agreement/contract requirements. Ensure accountability for CAPA implementation and closure following regulatory inspections and GSK audits. Evaluate and follow-up on change controls generated by the external provider, escalate to Steering Committee if needed. Ensure Quality Systems at external provider site are in line with GSK expectations, through appropriate oversight and efficient analysis tools. Investigate major/critical deviations, issues or technical complaints within the time frame defined. Identify and mitigate critical/major issues that could impair the performance of the activities.
- Track, analyse and communicate metrics to ensure efforts are implemented effectively and in line with quality goals, strategy and objectives. Identify improvement opportunities. Lead and perform a periodic Risk assessment regarding the external providers, he/she is responsible for.
- Identify, assess and mitigate quality risks adequately. Develop and maintain the in-scope audit universe and propose a fit-for-purpose strategy for the yearly audit planning, in accordance with business needs and requirements.
- Ensure proper archiving of quality records documentation to guarantee traceability during the required period of time in accordance with procedure, if relevant.

2. Interface with Procurement, Legal, Auditing Team and business partners including GSK Corporate, Consumer Healthcare and Pharma to ensure internal GSK alignment while remaining independent in his/her quality evaluation role.

3. Be the reference person in Quality for the R&D Third Party in several governing bodies such as but not limited to HBS Sourcing Board, Clinical Laboratories Sciences (CLS) Outsourcing Committee,...

4. Manage quality meetings (timeframe to be defined) according to a pre-defined agenda to review the quality performance, ensure highlights are captured and drive continuous quality improvement plan. Represent the Third-Party Quality team within various meetings and report points and issues within the defined timelines.

5. Remain current with industry trends and changes in the regulatory and external environment through established networks - to ensure that any issues likely to impact the external network are well understood and communicated in order to avoid disruption to services.

6. Support for audit-readiness status maintenance, preparation, conduct, follow-up for Audit & Inspection activities.

7. Escalate, manage and support issues management.

8. Contribute to the development, improvement & simplification of standards and processes across the Q4R&D Third Party department and in the context of the R&D QMS implementation

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