Quality Compliance Manager

Job Description:

As our Quality Compliance Manager you will be responsible for overseeing supplier management activities and managing Third Party relationships to meet quality obligations including release of Incoming Materials/Spare Parts and managing the Product Quality Review (PQR) and Site Quality Council process.
Additionally, this role is responsible for maintaining regulatory conformance across all operations, with products being manufactured and delivered in full compliance with applicable regulations, licenses, and pharmacopeial guidelines.

Further responsibilities:

* Lead the Quality Compliance team of 6 to provide services in the area of quality compliance, supplier audit management, supplier management, third party relationship, regulatory conformance and sustainable GMP culture to ensure Gödöllő site is always inspection ready.
* Review and approve quality compliance related procedures to ensure they are in compliance with QMS requirements.
* Manage GxP service providers to ensure they are qualified and periodically re-qualified to meet GSK requirements. This includes the management of qualification, service provider complaints and quality agreements.
* Manage and conduct audit programmes on site-managed key suppliers / service providers to ensure that they are operating in compliance with cGMP and regulatory requirements and support the performance review of these suppliers / service providers
* Manage the Product Quality Review process to ensure reviews are completed accurately within required timelines.
* Lead and drive site Quality Council to ensure robust quality governance, fostering a culture of continuous improvement and quality excellence across all site operations. Facilitate monthly Quality Council meetings, set agendas and track action items.
* Manage the Regulatory Compliance team resources in support of site's regulatory activities for strategic projects and questions or queries from health authorities for post approval changes and licenses renewal and new product launches
* Manage the provision of regulatory service to internal and third-party customers such that the compliance of site business activities is maintained.
* Manage, develop, and motivate staffs in the team to help realise their maximum potential to contribute towards achieving the objectives of the section and the department.

Basic Qualifications & Skills:
* University Degree in Scientific orientation, preferably in pharmacy or biology/chemistry, etc.
* Strong experience in the field of regulatory compliance
* Ability to manage and coach team, as you would be responsible for a team of 6 people
* Proficiency in both Hungarian and English languages

Preferred Qualifications & Skills:
* Experience with participating in inspections by major authorities as FDA, EMA
* Good interpersonal, communication (including presentation) and influencing skills
* Accurate data management skills
* Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks

What we offer:
* Hybrid working (2 days in HO per week) with flexible working hours
* Permanent contract
* Annual bonus and annual salary review
* Cafeteria (flexible benefits)
* Commuting support (company shuttle buses from Budapest and surrounding towns of Gödöllő, or fuel support if using your own car)
* Group life and accident insurance package
* Voluntary pension fund contribution
* Paid parental and caregiver leave
* Modern and clean working environment with an innovative culture

For further information watch our video summarizing our benefits: GSK Gödöllő juttatások (youtube.com)

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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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