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Cqa Audit Associate Director
Il y a 4 mois
**Site Name**: Belgium-Wavre
**Posted Date**: Feb 17 2023
This role will need you to provide Independent Quality Assurance to GSK R&D, by delivering the audit program including defining scope, conducting audit processes, reporting observations and ensuring delivery of audit report. You will identify compliance issues, monitor trends, be accountable for driving quality improvements back into R&D Business Functions and improve processes. You will support as well QA activities during regulatory inspections and build solid working relationships with Risk Managers and Ethics & Compliance Officers, establish a network of contacts, and maintain knowledge of local regulatory frameworks and global regulatory reporting requirements.
This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:
- Adhere to the core beliefs of the business and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
- Deliver and lead on multiple regulatory/clinical programs, and drive business initiatives.
- Serve as the regulatory and potential clinical representative on a therapy team and oversee project plans and develop strategies to support projects.
- Provide oversight and execution of the regulatory/clinical strategie.
- Responsible for the Implementation of the regulatory and clinical plan.
- Responsible for submission to regulatory agencies, including pre-submission and negotiation activities.
- Provide ongoing support of to product development teams for regulatory and clinical issues and questions.
- Serve as regulatory/clinical consultant to marketing or research project teams and government regulatory agencies.
- Monitor and/or interpret changing regulations to assure compliance to regulations.
- Provide support to currently-marketed products as necessary. This includes reviewing labelling, promotional material, product changes and documentation for changes requiring government approval.
**_ Why you?_**
Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in related Health Science field or equivalent. An advanced degree would reduce the work related experience requirement
- Broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance
- Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance is preferred
- Extensive knowledge of global, regional and national regulatory requirements and regulations
- Detailed knowledge of the drug development and clinical processes
- Ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization
- Demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies
- Demonstrated experience interacting with regulatory agencies
- Demonstrated ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively
- Organizational awareness and working towards resolution with complex problems
- Project management skills and management of cross-functional activities
- Ability for excellent verbal, written and presentation skills
- Ability and desire for frequent domestic and international travel (approximately 25-40%)
**_ 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. 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 Ahead Together.
LI-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make s
