Senior Specialist Technical Services

As Senior Specialist Technical Services for External Manufacturing, you will:

• Ensure, coordinate and support the manufacturing, technology and validation activities deployment for enabling External Supply (Supply & Quality Organizations) to deliver its strategic objectives as a Virtual Plant.
• Be the expert and SPOC for any technical and validations topics.
• Ensure the continuous technical and validation life cycle support at the CMO’s.
• Lead complex Continuous Improvement project with supply and financial impacts on the GSK Vaccines business.

Your responsibilities:

• Based on the transversal project portfolio, you coordinate and support the overall activities deployment (routine operation, field, technical support, and validation) for primary & secondary processes, and escalate any issue
• You are the validation and technical Single Matter Expert for External Manufacturing DP  
• You define the validation strategy to apply at the CMO and also support the evaluation team during the Change Control evaluation phase.
• You manage validation lifecycle for the international CMO portfolio.
• You ensure the availability of all documentation required to support validation activities.
• You support CMOs with the set up of all maintenance and requalification programs including the QC validation of equipment (IQOQ) and transversal equipment PQ (Autoclave, clean utilities, GMP washer, Incubators, thermostatic rooms,)
• You provide the adequate training support for technical related topics to the CMO, EM QA and Supplier Relationship Manager’s if needed.
• You define together with EM QA the adequate GMP standard for validation and technical topics integrating the local regulations
• You support the CMO with audit documentation and inspection readiness, and you prepare the local team through audit dry runs.
• You lead, using your technical expertise, a cross‑functional team to manage deviations and define CAPAs related to the technical domain
• You approve key (cornerstone) Technical documents for cross‑functional projects.
• You liaise with Engineering when support is requested for facility design or for custom‑designed process equipment.
• You identify and escalate potential risks within the framework of risk management.
• You support EM QA and SRM teams in the CMO evaluation, providing technical and validation expertise and assessing compliance levels.
• You support the CMO through regular site visits and teleconferences.

Why You?

Basic qualifications:

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

• University degree in the Pharma and/or Biotechnology field with experience in manufacturing/primary & secondary operations of vaccines/ Project Management (3 to 6 years)
• Scientific and technological know-how related to vaccine and medicine manufacturing operations.
• Knowledge of international regulations (FDA, PIC’s, WHO, Eudralex and local cGMP)
• Good knowledge of GSK Vx organization and inter relationships between all GSK Vx departments
• Stakeholder management (interaction with Quality, Regulatory and Manufacturing/QC experts)
• Good Command of English written and spoken, any other language is an advantage
• Social skills to foster teamwork of people belonging to different organizations/departments/sites

Preferred Qualifications:

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

• Continuous Improvement, orange belt qualification
• Sense of urgency, flexibility and accountability
• Experience in working in matrix organization

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 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.

Our department:

GIO

Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So, it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.

As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.

The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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