The Quality Compliance Manager is responsible for compliance oversight of quality systems and quality risks at the Marietta facility to ensure compliance with GSK procedures, policies, and standards and the regulations of all markets for which Marietta manufactures product. The Quality Compliance Manager is responsible for oversight of the inspection readiness status of the site and for the internal audit and external inspection programs.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Regulatory and Corporate Inspections: Act as the site regulatory expert, overseeing site compliance and conformance. Manage site inspections, lead teams to resolve audit issues, handle external partner interactions, negotiate workload conflicts, and coordinate and implement CAPA responses. Assess change controls for regulatory impact, review and approve regulatory submissions and dossiers, and maintain core files and the site master file.
- Internal Audits and Inspections: Manage the site level internal inspection program, oversee and follow up on reports, ensure audit training and regulatory monitoring, and manage CAPAs.
- Compliance and Quality System Management: Serve as the compliance expert for Marietta and the single point of contact for regulatory intelligence and regulation and guidance updates. Evaluate and report on quality system compliance and performance, maintain year-round inspection readiness, manage inspection readiness plans, mentor the inspection team, conduct audits, follow up with the Site Leadership Team, and measure and communicate QA compliance performance.
- Training: Oversee regulatory training, implement improvement projects, and manage the team.
- Leadership: Communicate vision and priorities, provide feedback, exemplify company values, develop team skills, ensure team cohesion, and maintain a safe working environment.
- Continuous Improvement: Promote continuous improvement aligned with company strategy and implement actions based on feedback from health authorities.
- Quality: Enforce sector-related procedures, update procedures, escalate quality issues, support deviation investigations, and participate in audits.
- Supplier Quality: Oversee the Supplier Quality Assurance program for the site to ensure the use of approved suppliers and approved service providers.
- Risk: Manage cGMP risks using the site risk management process. Integrate risk management and inspection readiness activities.
- Health and Safety: Enforce health, safety, and environmental procedures, ensure regulatory compliance, participate in risk analyses, enforce safety rules, report risks, and identify safety improvements.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
- B.S or B.A in a relevant scientific, quality system or technical discipline.
- 10 years prior experience in Quality Assurance or Quality Control (Quality Systems, compliance, product release, auditing) in the pharmaceutical field, especially having led regulatory audits and managed quality systems within clinical or commercial organization with licensed biopharmaceutical or biological products.
Preferred Qualifications:If you have the following characteristics, it would be a plus:
- Certification such as ASQ Certified Quality Auditor preferred.
- GSK Auditor certification or development as certified GSK auditor preferred.
- Previous leadership experience preferred
- Good understanding of strategic objectives and processes.
#LI-GSK#mariettavaccines#globalsupplychain#GSKmariettaPlease 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-###-#### (US Toll Free) or +1 801 ### #### (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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