Quality Processes Manager

GSK is currently looking for a Quality Processes Manager 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 Inspection Ready at all times

Key Responsibilities:

• Manage Quality Compliance/Systems/Processes team
• Manage various QA databases
• Present management review packages/periodic product reviews
• Make decisions based upon data trends
• Manage third party audits, prepare responses to observations from third party audits
• Participate in audits and act as an SME on Quality topics, prepare responses to observations from audits
• Provide guidance on cGMP regulations and guidelines
• Approve training plans and provide guidance on training issues
• Provide oversight to raw materials programs
• Manage Supplier Quality program and be a liaison with global teams

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 including a minimum of 2 years of 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.

#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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