GSK is currently looking for an Operational Quality Lead in Rockville, MD. The purpose of this role is to provide operational quality leadership and support for the deviations, laboratory investigations and CAPA management systems at the site. This role drives early detection and help prevent potential quality issues.

Key Responsibilities:

• Generate, support, coach, and approve investigations, laboratory investigations, corrective and preventative actions, including rapid response approach.
• Ensure Investigations are: Thorough, well written, have appropriate quality impact assessment, links between potential related events, root cause analysis is appropriately conducted, CAPAs established are based on identified root cause
• Review and approved closure of Corrective/Preventive (CAPAs) and Effectiveness checks.
• Provide information to support the Periodic Review process.
• Oversight of facilities, equipment, and personnel to ensure real time compliance to procedures, instructions, contemporaneous data integrity and other cGMP requirements.
• Generation, review and approval of quality system records and documentation, including change control, technical reports, and master batch records. Support/Perform Self Inspections, Internal audits, and Inspection Readiness efforts 
• Represent QA on product/project teams, in work group meetings, participate in facility design teams and specific drug product development teams
• Performs other functions as necessary or as assigned.

Why you?

Basic Qualifications:

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

• BS Degree in science, engineering, or other technical discipline  

Preferred Qualifications:

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

• 5 years GMP experience in a quality area.
• Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
• Demonstrate initiative and analytical problem-solving skills – ability to use and interpret data to drive decision making at both tactical and strategic level.
• Ability to work well under high pressure and deadlines
• Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes GSK Values, Behaviors and Strategies.
• Excellent verbal and written communication skills required.
• Conflict resolution and interaction management skills required.

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

*LI-GSK

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At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. 

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