Quality R&D Operations Drug Product Director

Are you looking to build an environment to optimize quality oversight, quality compliance, employee productivity and add value to the organization by actively leading a site or business team from a quality perspective? If so, this might be the opportunity for you!

As the Quality R&D Operations Drug Product Director in US, you perform the quality assurance activities and quality oversight of the US R&D Aseptic Drug Product filling for clinical materials. These are the activities performed at Upper Merion R&D Pilot Plant and the on-going project for R&D DP Pilot Plant under construction at Marietta.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

• Responsible for quality oversight, ensuring robust quality management systems are in place.
• Responsible for the timely release of material for clinical studies.
• Develop and implement strategy, policy and group objectives that build competency in quality assurance of clinical products.
• Detection, analysis, assessment, management, and communication of inherent and emerging risks and issues as well as subsequent management of mitigation actions.
• Accountable of the performance of the quality governance at local or functional level.
• Build continuous improvement into the processes and ways of working to optimize end to end quality and right first time.
• Lead the team in a dynamic matrixed environment by setting standards, objectives and measurements to drive business results and build a performance-based culture.
• Motivate, focus and develop the team in an inclusive environment to build a high performing team.
• Manage resources (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.
• Represent Quality R&D, providing relevant information to governance boards and one voice of GSK internally and externally.

Basic Qualifications:

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

• Bachelors degree
• Minimum 10 years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA)
• Minimum 5 years of experience in quality management roles within manufacturing
• Operational experience within a changing environment and more specifically for aseptic/sterile formulation, filling, freeze drying, visual inspection activities in a GMP environment

Preferred Qualifications:

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

• BA/BS in Pharmaceutical science, Biomedical or Chemical engineering or Science
• Master's or PhD in Science or Engineering
• Interpersonal skills with demonstrated ability to engage, empower and influence people
• Understanding of cGMP and regulations applicable to GSK in the relevant countries (FDA/EU/WHO and other countries)
• Experience within an R&D manufacturing environment
• Ability to evaluate product/technical compliance and quality issues and make sound recommendations regarding problem resolution
• Drive change and continuous improvement
• Able to work transversally in matrix organization, with global perspectives
• Ability to ensure a consistent approach in the interpretation and implementation of GMP/GDP standards
• Ability to evaluate risk and make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest
• Fluency in English both written and spoken

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

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

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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