R&D QP Release Manager (CDI)

Job purpose:

Within the current framework of the Investigational Medicinal Product operations in R&D (license 18 IMP), the QP Release Manager will ensure the QP certification and final release of new GMP vaccine candidates intended to be used in clinical studies and will ensure efficient and robust release systems and tools are in place.

The QP Release Manager is the first key contact regarding all release related questions for clinical lots related to his respective product development portfolio.

The QP Release Manager is a key interface between Q4R&D, TRD GMP, TRD, Regulatory, Clinical, Medical, GIO, Global functions.

The QP Release Manager will be the “voice” of the Qualified Person in any governing bodies either at local or global level.

The QP Release Manager will support the Qualified Person nominated and acting on the 18 IMP license ensuring that:

• GMP material used in clinical trials is manufactured, tested, released and distributed in conformance with GMP and regulatory requirements.
• GMP material used in Clinical trials is ordered, manufactured and released following approved Product Specification File (PSF) and aligned with the CMC part of the authorized clinical trial application
• Quality issues for clinical lots are correctly managed.
• The release system and all other QP related systems are fit for purpose

The QP Release Manager will also act as QP deputy during the nominated QP unavailability. The QP Release Manager is recognized as Qualified Person by Belgian Authorities under the Belgium regulation (Belgian regulation: Decembre 2006. — Arrêté royal concernant les médicaments à usage humain et vétérinaire

Your responsibilities :

• Ensure, in due time, the QP certification and final release of GMP vaccine candidates intended to be used in clinical studies.

• Support QP related activities in case of Issue management, recall and complaint.

• Ensure the Product Specification Files edition and support the system in order to ensure that materials used in Clinical Trials are ordered, manufactured and released following approved Product Specification File (PSF).

• Ensure and engage for review and effective execution of the Regulatory Submission Building Process (RSBP) and act as liaison between TRD GMP/TRD GMP Quality and GRA for any regulatory related questions (including questions on Change Control/Deviation/PSF).

• In his area of responsibilities, ensure critical issues are adequately managed; ensure identification and characterization of the issue, impact evaluation on quality, safety and efficacy of GSK products and potential impact on clinical data as well on GSK business; ensure timely escalation to upper management including remediation plan proposals.

• Ensure the R&D release system and QP related systems are fit for purpose and allow release of raw materials, intermediate products and final products for clinical use in compliance with Good Manufacturing Practices, Product Specification File and Regulatory Requirements. Ensure its continuous improvement and efficiency for both manufacturing & Supply and ARD GMP departments. Ensure R&D release system SME in Global network. Manage Expertise and training within the quality release teams to ensure compliance with the latest state of the art standards and industry practices.

• Represent QP/QA department positions/opinions views in all meetings related to the area of responsibility (staff meetings, deviations, CAPA, CC follow-up meetings).

• Support the nominated QP on a daily basis in all quality issues, QP related matters and QP related activities as needed.

• Be a QP deputy and act under the 18IMP license in case of unavailability of the nominated 18IMP QP

• Proactively identify and manage potential quality and business risks. Educate and influence by his behavior compliance to good quality practices.

• Is a key spokeperson front line during regulatory inspection

Why you?

Basic Qualifications :

We are looking for professionals with the following required skills to achieve our goals (must-have):

• Industrial Pharmacist. The candidate must be QP certified by the Belgian MoH as stated by Belgian regulation : (DECEMBRE 2006. — Arrêté royal concernant les médicaments à usage humain et vétérinaire
• 8-10 years in the Pharmaceutical/Biotech industry with significant experience of GMP within a major authority jurisdiction (EMA/FDA).
• 5-8 years in a quality management position with additional experience in production and/or quality control
• Deep understanding of the framework within which a pharmaceutical product has to be developed, registered and launched.
• In-depth knowledge and understanding of international legislation and regulatory standards.
• Expertise recognized in several fields related to release system

Preferred Qualifications:

The following characteristics are assets (nice-to-have):

• Ability to make independent decisions even under pressure.
• Strong interpersonal skills with demonstrated ability to engage, empower and influence people.
• French speaker while being fluent in spoken and written English.
• Ability to communicate complex information both orally and in writing.
• Ability to listen effectively.
• Ability to drive change.
• Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution.
• Has the technical competencies to evaluate investigations, product issues,
• Strong presentation skills - Capability to present in front of a national and international panel.
• In depth understanding of cGMPs and regulations applicable to the Vaccine industry in the relevant countries. (FDA/EU/WHO and other countries)
• Ability to adapt, work under uncertainty and accommodate flexible work demands.
• Global perspective
• Cultural sensitivity.
• Self-motivated
• Sense of urgency.
• Integrity.

• Li-GSK

GSKTechTalent

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.

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:

The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.

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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