GSK is currently looking for a Quality Processes Lead in Rockville, MD.

PURPOSE OF JOB ROLE:

Role has the Responsibility and Accountability for

• Developing and overseeing Quality systems
• Reviewing and approving GMP documents
• Determining department training requirements
• Serving as QA representative on project teams and managing QA projects when necessary
• Providing guidance to QA and other departments on Quality issues
• Ensuring site is always Inspection Ready

Key Responsibilities:

• Generate, support, coach and approve change controls Manage Quality Compliance/Systems/Processes team
• Ensure change controls are thorough, well written and follows the change control procedures
• Data provider for Periodic Product Review
• Manage various QA databases
• Participate in audits and act as an SME on Quality topics, prepare responses to observations from audits
• Oversight of engineering change controls
• Provide guidance on cGMP regulations and guidelines
• Write and review GMP documents.
• Represent QA in cross-functional meetings

Why you?

Basic Qualifications:

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

• BS/BA degree
• Minimum of 4 years of experience in biopharmaceutical or pharmaceutical industry
• GMP experience

Preferred Qualifications:

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

• Demonstrated sense of urgency.
• Breadth in quality systems principles and practical application.
• Demonstrated ability to effectively multi-task.
• Strong Project Management skills and delivery.
• Excellent verbal and written communication skills; with strong presentation skills.
• Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders
• Strong problem-solving skills.
• Demonstrated ability to work and collaborate in cross-functional teams.
• Demonstrated intercultural skills.
• Excellent written and spoken language skills; primary English and any secondary language is desirable.
• Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands.
• Capable of working independently.

Why GSK?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 Get Ahead Together.

#LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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