QA Em-v Manager

il y a 2 semaines

Wavre, 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 modern employer, we empower you to be yourself, share ideas and work collaboratively

**QA EM-V Manager - System and Support**

**In this role you will **
- Chair and coordinate the Quality Governance meeting within Quality EM-V team that may evolve from time to time (e.g.: Quality Council, Deviation CAPA Review Board,); Issue minutes on a timely manner, comply with write right principles and ensure appropriate escalation
- Drive and monitor the performance of EM-V Quality department by developing and monitoring Quality KPIs, managing follow up meeting (ex: deviation, capa, change controls, )
- Manage the complaints for EM-V with the support of CMO Quality Single point of contact
- Build a strong network with GSK External Manufacturing organization for best practice sharing
- Depending on business need, support QSPOC for Quality operational activities
- Support the batch release activity by coordinating the Manufacturing batch release documentation review, provide guidance as required
- Schedule daily operational activities with QA technicians
- Coordinate archiving of GMP documentation for QA EM-V
- Manage the Quality Alert and Quality Bulletin process for External Manufacturing Vaccines
- Chair and manage the External Manufacturing Quality Governance meeting (e.g.: Quality Council, Deviation/CAPA Review Board, Change Control Board )
- Act as SME (Subject Matter Expert) within External Manufacturing Organization for the different Quality Systems (Release, Documentation, Complaint management, PQR,...)
- Support the QSPOC to ensure the timely release of commercial batches in compliance with the Good Manufacturing Practices and regulatory requirements
- Develop and monitor Quality KPIs for EM-V
- Maintain the compliance level with GMP regulations / requirements and GSK Biologicals standards within the EM-V

**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**

**_ Why you? _**

Qualifications & Skills:

- Masters in Life Science (biomed, bio engineering, biology, chemistry, pharmacist)
- 5 to 10 years of experience in pharmaceutical industry
- Experience as QA or production manager, with expertise on the field, in quality systems and/or release
- Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
- Fluent in English and French

Preferred Skills:

- Strategic thinking
- Ability to engage, influence and lead people
- Ability to work autonomously and effectively in a highly matrixes organization
- Ability to obtain information and identify key issues and relationships relevant to a long-range quality goal or vision; committing to a course of action to accomplish a long-range goal or vision after developing alternatives
- Ability to communicate complex information both orally and in writing. Ability to listen effectively
- Ability to withstand pressure. Self-motivated; Sense of urgency
- Demonstrated ability to be efficient in a matrix organization to ensure effective use of resources and communication of issues to all impacted sites/functions
- Leading and influence capabilities at all levels of the organization with an inclusive mindset

**#Li-GSK**:
GSKTechTalent

**_ Why GSK?_**:
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 t

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