Manager QA Operations

il y a 2 jours


Wavre, Belgique GSK Temps plein

Ready to help shape the future of healthcare? Your talent can bring our science to life

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

**_
Manager QA Operations_**:
**Job purpose**:

- Act with colleagues of the production team and Primary / Secondary Quality Assurance Team to ensure the continuous supply of vaccines in line with GSK business objectives to meet customer needs.
- Monitor and analyze quality performance targets for the MPU
- Ensure regulatory compliance and audit readiness of the MPU in collaboration with the QA Release, Trending and Compliance manager
- Be responsible for implementing and monitoring the GSK Vaccines quality strategy within the operations of the MPU.
- Be responsible for the leadership of the operational QA within the MPU.

**In this role you will be in charge of the following areas**:

- Quality Assurance_
- Ensure adequate QA oversight on all production, maintenance and calibration deviations both in terms of content (root cause and CAPA’s) and timeliness
- Ensure any deviations, CAPA, change control, maintenance and calibration plan are reviewed and handled in accordance with procedures and in a timely manner
- Timely escalate critical deviation and major risks to management
- Ensure adequate QA oversight on all production change controls both in terms of content and timeliness
- Ensure all master production documentation are in line with validation and regulatory files.
- Ensure building and equipment are under validated stage and CVP, VP, QSR, TCD, periodic requalification for your MPU are timely approved.
- Act as a key player in the continuous Quality and Compliance improvement in collaboration with QA compliance manager.
- Prepare and participate to regulatory inspections: be a front-line spokesperson for all operational quality related aspects during inspections
- Provide QA expertise to support new project or new product introduction in the MPU.
- Ensure QA representation and decision making in all meeting related to your area of responsibility
- Ensure deployment of GMP training to QA and MPU personnel.
- Master the key QA activities related to production, QC, maintenance, calibration, and validation in your area of responsibility
- People Management and Development: _
- Lead, select, train, evaluate, coach and motivate QA operational team towards the pursuit of operational excellence and attainment of Good Manufacturing Practices
- Manager people through effective performance management and labor relations excellence
- As a leader, personally role model and develop the team towards high performance behaviors
- Ensure succession is in place for key roles in your organization to minimize operational risks
- Engage the team to deliver the GSK Vaccines, GIO and Quality strategy
- Site Representation: _
- Participate in external audit as appropriate
- Change and Process Management: _
- Implement change initiatives involving processes, technologies and people which contribute to the overall effective improvement of Quality within the MPU
- Share and integrate best practices within the Vaccines Quality Network.

**_
Why you? _**
- Qualifications & Skills:_
- University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
- Minimum of 7 years’ experience in a pharmaceutical / biotech / medical device / food industry or equivalent environment
- Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
- Successful team leadership experience
- Master the key QA activities related to production, QC, maintenance, calibration, and validation in your area of responsibility
- French speaker with good level of written and spoken English
- Preferred Qualifications & Skills: _
- Relevant quality experience, not necessarily within a quality department
- Experience with clean or aseptic manufacturing is an asset for certain manufacturing units
- Substantial knowledge of regulatory, GMP and legal requirements relating to QA needed
- Strong knowledge of cGMP and guidelines (FDA/EU/WHO)
- Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well-developed relation building skills to gain trust and credibility and to build a great place to work and good social climate
- Demonstrated impact and influence

Li-GSK

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.

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 t


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