Senior Compliance Specialist

Site Name : USA - Montana - Hamilton

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Posted Date : Sep 5 2024

As a Senior Compliance Specialist, you will support a multi-discipline team whose areas of responsibilities include : Leading investigations, CAPA management, Lean / Six Sigma program, project management within manufacturing and SAP, use of the SAP template with specific focus on the Production Execution (PEX) module of SAP.

This role requires you to operate as an internal Manufacturing liaison to other manufacturing teams as well as the following site organizations : Quality, Manufacturing Science and Technology, Technical Services, Environmental Health and Safety, Process Safety Management and Business Process Management.

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

• Promote a highly safety conscious culture and EHS focused workforce.
• Support department supervisors to ensure that all operations throughout Manufacturing are in accordance to approved GSK process safety standards and OSHA requirements.
• Perform all job responsibilities in compliance with applicable regulations, current operating procedures and industry practice.
• Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times.
• Acquire and maintain knowledge and understanding of SAP Production Execution (PEX) processes and understanding of manufacturing processes in order to manage the flow of materials appropriately.
• Support the integration of new applications with SAP at the Hamilton site (i.e. Manufacturing Execution System (MES)) as well as support Global Business Owners (GBO) in the analysis of the Hamilton site role assignments.
• Perform project management duties related to projects ranging from single department, small scope projects to multi-department, large scope projects.
• Perform and monitor manufacturing processes using a highly automated approach based upon Emerson’s Delta V platform. Troubleshoot process deviations resulting from automation communication issues.

Why you? Basic Qualifications :

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

• Bachelor's Degree in any Discipline and 5+ years of cGMP / healthcare / lab related experience OR
• High School Diploma and 10+ years of cGMP / healthcare / lab related experience

Preferred Qualifications :

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

• Regulatory inspection experience
• Knowledge of biological / vaccines manufacturing and its management, including relevant regulations governing the manufacture and supply of pharmaceutical products
• Project management experience and knowledge of best practices associated and clear understanding of project management tools and approaches
• Experience with SAP management demonstrating a quality mindset and knowledge of business processes in the pharmaceutical industry
• Experience with Delta V automation

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 and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.

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