Manager QA Operations

il y a 3 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

  • Manager QA Operations

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

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

  • QA Distribution

    il y a 1 semaine

    Wavre, Wallonie, Belgique Jefferson Wells Temps plein

    Location:Wavre#23962QA Distribution (GDP)Wavre - ContractingOur partner is looking for a QA GDP to join its team. The purpose of the mission is to support the Quality for Supply Chain team, being a quality partner for some of the distribution related activities. The mission also consists in supporting the operational quality assurance management of Wade...

  • QA Distribution

    il y a 3 jours

    Wavre, Belgique Jefferson Wells Temps plein

    Location: **Wavre** **#23962** **QA Distribution (GDP)** **Wavre - Contracting** Our partner is looking for a **QA GDP **to join its team. The purpose of the mission is to support the Quality for Supply Chain team, being a quality partner for some of the distribution related activities. The mission also consists in supporting the operational quality...

  • Specialist, QA

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-WavrePosted Date: Mar 7 2023**_ Specialist QA Validation Technical Service Formulation_**:Ready to start with a new challenge? Do you want to join a great team in a stimulating and innovative environment? Do you have a quality mindset and a desire to learn?This position is for youThis position will allow you to be part of the QA...

  • QA Validation

    il y a 4 semaines

    Wavre, Wallonie, Belgique Randstad Temps plein

    We are looking for a QA Validation Senior for one of our clients based in Braine-l'Alleud/Wavre.Don't hesitate to contact me : anne- - Life Sciences Wallonie.This is a contract as a Consultant (employee or freelance): project from May 2024 to December 2024.responsabilitésAs a QA Validation Senior, your task will consist of: To ensure an efficient and...

  • QA Validation

    Il y a 2 mois

    Wavre, Wallonie, Belgique Randstad Temps plein

    We are looking for a QA Validation Senior for one of our clients based in Braine-l'Alleud/Wavre.Don't hesitate to contact me : anne- - Life Sciences Wallonie.This is a contract as a Consultant (employee or freelance): project from May 2024 to December 2024.responsabilitésAs a QA Validation Senior, your task will consist of: To ensure an efficient and...

  • QA Sterility

    il y a 1 semaine

    Wavre, Wallonie, Belgique Jefferson Wells Temps plein

    Location:Wavre Type:Contracting#20789QA SterilityBrabant Wallon - contractingOur partner is looking for a QA Sterility to join its team. This international company is well-known for its pharmaceuticals and vaccines.What are your responsibilities?You will provide support and expertise to the operations to ensure that the Manufacturing Performance Unit applies...

  • QA Validation

    il y a 2 semaines

    Wavre, Belgique Jefferson Wells Temps plein

    Location: **Wavre** **#23688** **QA Validation** Walloon Brabant - contracting You have experience in **quality assurance **and** validation** in the **pharma** sector? You have an eye for details and for work well done? Keep reading your future job description. Our partner is looking for a **QA Validation** to join its team. This international company...

  • Senior Specialist QA External Manager

    il y a 3 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre, GSK Tres Cantos, Madrid **Posted Date**: Mar 17 2023 **_ QA Manager External Manufacturing - CMO _**: - Job purpose: _ - Take responsibility for the Contract Manufacturer Quality oversight quality aspects (QA and QC) within the group of Tech Transfer / External Manufacturing Operations. - Ensure the release of the commercial...

  • Senior Specialist QA External Manager

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-Wavre, GSK Tres Cantos, MadridPosted Date: Mar _ QA Manager External Manufacturing - CMO _: Job purpose: _ Take responsibility for the Contract Manufacturer Quality oversight quality aspects (QA and QC) within the group of Tech Transfer / External Manufacturing Operations. Ensure the release of the commercial batches in compliance with the...

  • Specialist QA

    il y a 5 jours

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Jun 25 2024 **Job Purpose**: An operational role responsible for the QA oversight of operations in his/her areas of responsibilities. - Promote, master and ensure quality systems and cGMPs are in place in use. - Responsible of quality decision regarding products/activities. - Manage a team of Technician (not...

  • QA Validation Specialist

    il y a 3 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Mar 17 2023 **Specialist QA Validation & Technical Service - Filling department**: You will ensure the respect of the Quality systems and processes linked to Validation and Technical Services (TS) activities for the Filling Department (WN16 building). This role is ideal for you if you're looking to work in an...

  • Coordinateur QA

    il y a 1 semaine

    Wavre, Wallonie, Belgique Jobmatch Temps plein

    **_Votre défi :_**- Rédiger et/ou assister au développement, à la révision, à l'implémentation de documents QA par rapport au GMP ;- Signer les protocoles et rapports (dans le respect des procédures) ;- Approuver tous les documents au niveau QA ;- Réaliser des audits internes et défend le système qualité lors des audits externes ;- Coordonner,...

  • QA Validation Specialist

    il y a 1 semaine

    Wavre, Wallonie, Belgique GSK Temps plein

    Site Name: Belgium-WavrePosted Date: Mar Specialist QA Validation & Technical Service - Filling department:You will ensure the respect of the Quality systems and processes linked to Validation and Technical Services (TS) activities for the Filling Department (WN16 building). This role is ideal for you if you're looking to work in an innovative and ambitious...

  • Coordinateur QA

    il y a 3 semaines

    Wavre, Belgique Jobmatch Temps plein

    **_Votre défi :_** - Rédiger et/ou assister au développement, à la révision, à l’implémentation de documents QA par rapport au GMP ; - Signer les protocoles et rapports (dans le respect des procédures) ; - Approuver tous les documents au niveau QA ; - Réaliser des audits internes et défend le système qualité lors des audits externes ; -...

  • Coordinateur QA

    il y a 2 semaines

    Wavre, Belgique Jobmatch Temps plein

    **_Votre défi :_** - Rédiger et/ou assister au développement, à la révision, à l’implémentation de documents QA par rapport au GMP ; - Signer les protocoles et rapports (dans le respect des procédures) ; - Approuver tous les documents au niveau QA ; - Réaliser des audits internes et défend le système qualité lors des audits externes ; -...

  • Specialist, Validation and Sterility Assurance QA

    il y a 4 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: May 3 2023 **Specialist, Validation & Sterility Assurance QA**: The QA TS/Validation department is responsible for ensuring overall quality standards are met for products. Responsible for programmes to establish and maintain quality standards of existing products and services, as well as developing programmes...

  • Specialist, QA

    il y a 3 semaines

    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Jul 5 2023 **_ Specialist, Operational QA, Live Viral Vaccines_**: An operational role, with the responsibility for quality oversight of the manufacturing of live viral vaccines. **In this role you will**: - Ensure regulatory compliance of operations and escalate major quality issues and/or compliance gaps -...

  • QA Specialist

    il y a 1 semaine

    Wavre, Wallonie, Belgique 1849 GlaxoSmithKline Biologicals S.A. Temps plein

    Job Title: Quality Assurance Specialist at GSKMaster the key Quality Assurance (QA) activities related to production, QC, maintenance, calibration, warehouse, CSV, validation, and project activities in your area of responsibilityEnsure timely release of batches of intermediate products related to your area of responsibilityReview and handle deviations,...

  • Specialist QA Investigational Medicinal Product

    il y a 3 semaines

    Wavre, Belgique GSK Temps plein

    Ready to help shape the future of healthcare? Your talent can bring our science to life! As a, we empower you to be yourself, share ideas and work collaboratively **_ Specialist QA Investigational Medicinal Product (IMPQ)_**: **Job purpose**: - You act with colleagues of CM&S Quality and our partners to ensure the continuous supply of clinical vaccines in...