GSK is currently looking for a QA Compliance Lead to join our team in Rockville, MD. In this role you’ll lead the site to ensure all relevant Quality Systems are in place, in use and effective to ensure an environment whereby the site is inspection ready and able to support successful regulatory, third party and central inspections.

Key Responsibilities:

• Manage end to end third-party, central and regulatory inspections
• Participate in regulatory agency audits and act as an SME on Quality topics.
• Manage Quality Risk Model
• Manage various QA databases
• Manage Management Review by Quality Council preparations and output
• Write and review GMP documents.
• Develop and facilitate trainings.
• Participate in Internal Audit Programs (IBM, external supplier audits and Management Monitoring)
• Extended working hours may be necessary to support inspections

Why you?

Basic Qualifications:

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

• BS/BA degree
• 4+ years of GMP experience
• Inspection-readiness and audit experience

Preferred Qualifications:

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

• FDA audit and response experience
• 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

#LI-GSK

The annual base salary for new hires in this position ranges from $110,550 to $184,250 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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