R&D Quality Manager

Are you a Quality Professional seeking a new opportunity to make a difference and contribute towards defeating diseases? If yes, this position may interest you.

As a RD Quality Manager, you will oversee the quality of early to late-stage research and development activities for Vaccine candidates to ensure compliance with both regulatory and GSK standards. You will be responsible for deploying and executing quality processes, as well as simplifying processes to support the delivery of pipeline development milestones.

This role offers you the chance to work in a complex matrix organization, with a high number of stakeholders and a diverse range of activities in scope. It is an excellent opportunity to advance your career, with responsibilities that include:
- Performing non-GxP quality oversight of Pre-Clinical and Technical R&D activities.

- Performing GMP quality oversight of Analytical R&D activities.
- Managing stakeholders and creating partnerships to implement and maintain fit-for-purpose quality framework and quality culture
- Ensuring that the activities conducted in the R&D environment comply with GSK standards and any relevant international regulations and guidelines
- Supporting inspection readiness as needed for the R&D functions
- Designing and executing initiatives, alone or in partnership, to improve efficiency, partnership, and fit-for-purpose quality assurance and quality culture at the R&D site.

Role Responsibility:

• Quality oversight on R&D projects (Discovery, Drug Substance, Drug Product, Analytical) according to the GSK fit-for-purpose quality framework. This should include: non-clinical GLP studies, Equipment and Computerized System Management, Deviation/ Change Control and CAPAs, Escalations, Internal/External audits and Quality Governance, among other topics.
• Contribute to Local and global Q4R&D Quality Projects as per agreed objectives and Quality Plan.
• Represent Quality at the relevant functional and quality governance bodies.
• Represent Quality at R&D global initiatives level (e.g R&D QMS)
• Leads alone or in partnership design and implementation of innovative solutions to enhance the existing Quality Framework to deliver compliance and efficiency.
• Provide input to risk management and management monitoring activities.
• Proactive, risk proportioned quality input to R&D non-GMP processes and systems including quality review and approval of relevant written standards.
• Prepare and support the R&D functions for the audits performed by GSK (L2/L3 audit) and/or by external Health Authorities (L4 Audit) as applicable.

Why you?

Basic Qualifications:

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

• Bachelor’s degree in Pharmacy, Science, or an engineering discipline, Chemistry, biology, bioengineering or pharmacy or equivalent.
• Min. 5 years in the pharmaceutical business in vaccines covering various areas: Technical research and development, preclinical, manufacturing.
• 5+ years of Manufacturing/Quality experience in the pharmaceutical industry.
• 5+ years' Experience with the application of Quality Systems in manufacturing, warehousing and distribution.

Preferred Qualifications: Preferred Qualifications:

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

• Master's Degree is preferred.
• Ability to work independently and prioritize workload.
• Excellent oral and written communication skills.
• Strong interpersonal skills with an ability to enable and drive change.
• Problem identification and solving skills.
• Experience of working with multi-functional teams.

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:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

• Continuously looking for opportunities to learn, build skills and share learning.

• Sustaining energy and well-being.

• Building strong relationships and collaboration, honest and open conversations.

• Budgeting and cost-consciousness.

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