SVP, Head of Quality Vaccines

Senior Vice President, Head of Quality for Vaccines

An exciting highly visible and influential senior leadership role that contributes significantly to development of the GSK Vaccines strategy, objectives and goals, measures, performance targets, strategic initiatives and capital investment plan.

About the Vaccines Portfolio

In 2020, we sold 582 million doses of vaccine around the world. Our global footprint includes 12 manufacturing sites and three Research and Development Centers dedicated to vaccines and our R&D focuses on developing vaccines against infectious diseases that combine high medical need and strong market potential.

Our vaccines have been helping to protect people from serious disease for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882. Today, our vaccines continue to tackle some of the world’s most devastating diseases, including pneumococcal disease, meningitis, hepatitis, rotavirus, whooping cough and influenza.

Our leadership in Vaccines is driven by:

• Global reach and commercial execution
• World class manufacturing capability and scale
• Industry-leading pipeline, FiC / BiC potential, 16 Phase 2/3 assets
• Unrivalled portfolio and breadth of technology platforms

Our ambition:

• High single digit % sales CAGR 2021-26
• Advancing COVID solutions
• 5 planned new launches by 2026, including £multi-billion RSV opportunity
• Doubling Shingrix revenues in 5 years
• Ambition to double meningitis sales and flu sales in next 10 years

About Vaccines Quality and Manufacturing

Our global network of vaccine manufacturing sites includes facilities in Belgium, Germany, Singapore, the USA, France, Canada and Hungary. Vaccines manufacturing is complex and, for some of our vaccines, the production process can take up to two years.

On average, each batch of vaccine will have undergone more than 100 quality checks to ensure that it meets world-class standards before it is released. Each of our vaccines is produced to the same quality standard, regardless of where in the world it will be used.

We are continuously investing in our manufacturing facilities, improving our processes and building partnerships to ensure we meet the growing global needs for high quality vaccines.

Shingrix

Our breakthrough shingles vaccine, Shingrix, was approved for the prevention of shingles in adults aged over 50 by the FDA in October 2017, and by the European Commission in March 2018, and was recognized as the most successful biopharma launch in the past 10 years in North America. Today, Shingrix has become the gold standard for shingles prevention with unprecedented high efficacy >90% with proven 4-year duration of protection.

2020 was a tough year for Shingrix due to a decline in demand in the US caused by lower adult wellness visits and vaccination rates during the COVID-19 pandemic. Nevertheless, sales grew again to £2.0bn, primarily driven by a strong performance in Europe and launch in China, and we expect US demand to recover strongly. Shingrix currently has 99% percent market share of the Shingles vaccine market.

Major opportunity in the US, China and beyond makes us aim to double revenues in the next five years. With unconstrained supply to support growth ambition, geographic expansion to 35 markets within next 3 years is planned. Active life cycle management and label expansion provide us the potential to expand its reach by increasing the coverage in eligible adults in the US and through extending its indication to younger, immune-compromised adults. A fully liquid formulation is also planned.

Meningococcal franchise

We aim to double revenues in the next decade, building on world leading MenB vaccine.

GSK Vaccines has the potential best in class portfolio and pipeline. As market leader, we have more than 50% share in a GBP2B market with proven benefit backed by real world evidence.

While sustaining leadership and expanding market with Men ABCWY, currently in Phase 3, we expect to launch in 2024. Our 2nd Gen ABCWY, currently in Phase 1-2, has the ambition to provide the world’s broadest coverage for all ages with improved convenience.

RSV

RSV Older Adults is our most advanced RSV vaccine candidate - in Phase 3 and is leveraging our proven adjuvant technology and has first- and best-in class potential with £multi-billion opportunity

RSV Maternal has the potential to provide broad protection to infants from first breath of life. The polyclonal protection with potential game changing RSV pertussis combo will follow.

Influenza

We are continuously innovating to deliver greater protection, with new ambition to double revenues in next decade. Our pipeline aims to include innovative plant-based protein adjuvanted vaccine for 65+ segment, a next generation mRNA vaccine and a transformational universal flu vaccine & add-on mAb providing higher efficacy

COVID-19

Since the pandemic began, we have been seeking ways to harness our scientific expertise and technology to make a difference. As a result, we are working with several partners to develop potential COVID-19 vaccines and treatments as quickly and safely as possible.

We have joined forces with Sanofi, combining their vaccine candidate with our adjuvant technology to develop an adjuvanted COVID-19 vaccine candidate. An update was issued in December 2020 on the phase 1/2 clinical trial. In May of this year, both companies started enrolment in their global, randomized, double-blind placebo-controlled Phase 3 study, including more than 35,000 volunteers.

We are also collaborating with Canadian biopharmaceutical company, Medicago, to develop a COVID-19 vaccine by combining their plant-derived vaccine candidate with our adjuvant technology. The vaccine candidate entered phase 3 clinical trials in March 2021.

In February 2021, we announced that we will work with CureVac to jointly develop next generation mRNA vaccines for COVID-19 with the potential to address multiple emerging variants.

This new COVID-19 agreement builds on the existing relationship between GSK and CureVac. In July 2020, we announced a strategic collaboration to research, develop, manufacture and commercialize up to five mRNA-based vaccines and monoclonal antibodies. GSK also made a £130m equity investment in CureVac.

We have also scaled up manufacturing of our pandemic adjuvant across our global network to support the adjuvanted COVID-19 vaccines in development through our collaborations. We have committed to supply our adjuvant to governments and institutions at a responsible price, either as standalone adjuvants or as part of an adjuvanted vaccine, and we will make it available to all countries, including the world’s poorest nations.

We do not expect to profit from our vaccine collaborations during the pandemic. We will re-invest profits made on sales of our adjuvant during the COVID-19 pandemic phase to support coronavirus related research and long-term global pandemic preparedness.

About the role – Senior Vice President, Head of Quality for Vaccines

The Senior Vice President Vaccines Quality, provides overall leadership, direction and focus for Quality to the Vaccines products at GSK and will be a member of the Vaccines Leadership Team (VLT).

This is a highly visible and influential enterprise leadership role that contributes significantly to development of the GSK Vaccines strategy, objectives and goals, measures, performance targets, strategic initiatives and capital investment plan.

The scope includes QA/QC for Manufacturing (12 sites and multiple CMOs) and Research & Development globally (three main R&D centers in Belgium, US and Italy). The total team size is approximately 3,300 people, including 11 direct reports, plus additional leadership responsibilities for contractors, suppliers and local operating companies.

The role will preferably be based in Belgium.

Key responsibilities

• Provide strategic direction and management of Vaccines Quality organization.
• Ensure the successful implementation of the Quality Management System within GSK Vaccines.
• Ensure that product governance goals for GSK Vaccines are achieved.
• Defend the quality position for both manufacturing and research to external regulatory bodies.
• Provide regular updates regarding quality issues and recommend the correct course of action, as well as risk assessment to VLT, Corporate Executive Team, CEO and Board of directors.
• Assure quality and GxP compliance (including GMP, GLP, GCLP, GSP requirements) in the research, development, manufacturing and release of all GSK Vaccines products.
• Lead all those responsible for GxP quality assurance across all global locations and departments.
• Key member of the global Industrial Operations Leadership Team (IOLT) and together with colleagues responsible for ensuring a continuous supply of vaccines in line with GSK business objectives to meet customer needs.
• Member of the GSK Recall Committee and GSK Global Quality Council.
• Accountable for development and management of global quality standards and processes throughout the product lifecycle
• Ensure that all GSK Vaccines products developed and manufactured through the internal and external network, meet all required Quality standards and GxP compliance in research, development, manufacturing and release.
• Direct the management of all quality incidents and recalls to minimize the adverse impact on GSK Vaccines products and plant assets.
• Ensure GSK Vaccines has a robust plan to comply with all aspects of Regulators’ requirements, including the proactive avoidance of adverse audits and regulators observations, and directing and supporting remediation actions in response to such findings when they occur.
• Lead the governance process to ensure risk management and mitigation for Quality and Compliance issues (Global Quality Council).
• Ensure, through proper audit resources/programs and operational oversight, that suppliers and contract manufacturers comply with GxP requirements and meet GSK quality expectations.
• Ensure that GSK GxP Compliance/Inspection Readiness plans and internal audits/assessments meet GSK and regulatory compliance requirements.
• Oversee the continuous professional development of Quality personnel to ensure that there is a proactive talent management strategy to deliver succession planning for all key roles in the Vaccines Quality organization.
• Provide leadership and support to the GSK Vaccines quality governance and advocacy approach with health regulators and government agencies.
• Lead the Vaccines Quality Leadership team to ensure Quality resources are optimally organized to support Vaccines supply chain activities (including project support and other key Quality initiatives.
• Lead, coach and develop the members of the Quality Leadership team, guiding them through sometimes difficult situations and providing a point of escalation.
• Contribute to due diligence review of potential acquisitions.
• Guide and lead the evolution of the Vaccines quality function into the future, defining the organization for the next 5-10 years and managing the ongoing process of greater digitalization and transition to predictive quality assurance.
• Work across functional boundaries to position the Quality function as true partners delivering the best service and maximizing the value to the business.

Why you?

Basic Qualifications:

• Strong academic background including university degree in a scientific/technical discipline.
• PhD in Chemistry, Biology or Pharmaceutical Science and/or business management qualification is preferred.
• More than 20 years’ experience in (bio)pharmaceutical supply chain, manufacturing and/or quality operations.
• Experience and credibility in quality management at senior executive/enterprise leadership level in a complex life sciences organization.
• Extensive knowledge of regulatory requirements and working experience and credibility with regulatory authorities, particularly in Europe and the US.
• Solid technical expertise in sterile biologics with complex biological manufacturing processes, preferably including vaccines.

Preferred Qualifications:

• Experience including marketed products and ideally also development products.
• Ability to recognize and focus on the critical issues and delegate effectively.
• Demonstrated ability to lead effectively in a complex matrix organization.
• Demonstrated success in building a strong team and developing organizational capability in Quality Assurance.
• Courage to lead decision making on Quality issues and challenge appropriately.
• Ability to inspire, partner and coach the organization to improve performance.
• Excellent influencing and negotiating skills and verbal/written communication skills.
• Strong networking and collaboration skills in a complex environment.

Why 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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• An approachable, down-to-earth, straightforward, resilient and persuasive personality, with strong negotiation, communication and influencing skills and an ability to drive change.
• A self-confident, well-organized, proactive self-starter, you will roll up your sleeves and delve into the detail on key business issues.
• The strength of character to speak his/her mind, combined with the sensitivity, judgement and tact to know when to insist and when to pull back. A good listener.
• Unquestioned ethics and integrity.
• High energy and drive.
• Leader with powers of persuasion and effective negotiation skills.
• Proven problem solving and analytical skills; seen as a problem-solver but prepared to stand up in the interests of the company.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.