VxA&S: Head of Analytical Improvement and innovation

Job Purpose:

The QC operations are critical to the timely launch of new vaccines and to support the supply chain of marketed vaccines with the highest criteria of quality.

The present portfolio includes around 30 different vaccines representing about 40 different antigens, tested in different QC teams in various buildings or sites using different analytical technologies (biological, immunochemical, physicochemical and biochemical technologies). In this aspect the Director New product Analytical Strategies and Innovation defines and deploy analytical strategies within QC through collaboration with the AS&T and QC Networks. He/She organizes and leads the introduction of new technologies through the innovation hubs of R&D and Global QC. He/She facilitates the introduction of new products in QC, supports and solves analytical issues on legacy products.

In addition, He /She leads the support to MPUs/SPUs in their investigations, process evaluation/Validation activities and Continued process Verification.

Your responsibilities:

• Lead and organize life cycle management of analytical tools across the whole QC department in close collaboration with R&D, Global QC MSAT and Process Sciences.

• Develop and/or clarify analytical strategies to help solving technical issues to guarantee the continuity of supply in compliance with current regulations, drive the follow-up of these plans to ensure milestones are reached. Coach/Mentor local SMEs/ATEs (Method Validation, Technical expertise, Automation, Reagent and Standards, Innovation)

• Lead, the Biological Material management accountable for establishing and executing strategy related to planning and validation of QC Biologicals Materials used QC in the networks and National Control Laboratories.

• Manage TRD interface by challenging technical approaches and analytical strategies arising from the implementation of new projects to comply with QC requirements;

• Drive the evolution and the continuous improvement of the Analytical Methods Validation and tests lifecycle (robustness) as well as the compliance with the different evolving Regulatory needs, existing legislations / guidance’s and pharmaceutical companies’ general trend. Promotes the use of innovative approaches (i.e. Quality by Design, Design of Experiment,) for the AMV activity and control strategies for vaccines under development and Life-Cycle vaccines.

• Act as central point of contact for QC by interacting with other GSK Bio departments (GQC, RA, QA, TRD, GIO MSAT and Process Sciences regarding analytical method validation , analytical method lifecycle. Support operational QC units to facilitate the introduction of the new technologies and/or troubleshooting of existing analytical methods

• Analyze new or revised regulatory guidance or new analytical methods and techniques and understand whether there are modifications Provide concrete proposal to address issues. Highlight issues and proposals to Bio QCLT management Team.

• Anticipate innovative technologies and automation, digitalization for smooth implementation within QC

• Build a network of internal and external collaborations to support QC technical operations; develop a knowledge management network around analytical strategy through Global System Owner for AMV

• Implement new ways of working to increase the output, rationalize current technical practices and meet cost and time criteria; and promote the technical expertise in QC. Act as a mentor for QC laboratories in the network.

Basic Qualifications:

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

• Master degree in Life Sciences (Biology, Biochemistry or Chemistry)

• Advanced expertise in analytical techniques, deep knowledge of cGMP

• At least 10 years’ experience of analytical expertise in a quality control environment. These activities would have been performed in a Pharma or Biopharma environment.

• A thorough knowledge of Bio products and of early and late development projects as well of vaccine characterization and assay development

• Proven technical expertise to gain trust and support mainly within the Operational QC Units, TRD and RA, MSAT organizations;

• Expertise in a large panel of macromolecules (recombinant proteins, polysaccharides, adjuvant systems, excipients, raw materials)

• Strong expertise in Analytical Processes (Validation, Transfers, Specifications)

• Ability to identify issues and to seek continuous improvement in technical operations;

• Ability to manage interface and to build a network of collaborations across the company and outside (Interactions with all teams within QC and across the GSK vaccines Sites.;

• Acknowledged ability to plan, manage and lead cross-functional teams and projects to meet business objectives;

• Important leadership skills to maintain the team motivation in a transversal organization and in a complex and moving environment

Preferred Qualifications:

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

• Strategic thinking, Communication, Presentation skills, Synthesis capacity, spoken & written English, Negotiation, Facilitating, Influencing, Project management, Flexibility (mental agility), Mobility

• Knowledge of early and late development projects;

• Knowledge of GSK Bio processes;

• Knowledge of QA environment;

• Deep knowledge of cGMP;

• Good knowledge and understanding of GSK Bio global scientific and product development strategy and objectives. Integrate this knowledge in decisions and recommendations.

• People management and social skills to foster teamwork and to coach collaborators (highly transversal profile)

• Analytical and critical mind, global and pragmatic approach, problem solving;

• Proven ability to communicate and negotiate effectively with all levels of management;

• Excellent negotiation skills with stakeholders and third parties, impact and influence and change management skills;

• Leadership of teams including different departments;

• Excellent knowledge of written and oral English

• Lean Culture deployement expertise

• Li-GSK

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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