Clinical Quality Assurance Audit Associate Director - Roma, Italia - GSK

GSK

Azienda verificata

Roma, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Site Name:
Belgium-Wavre, Dresden, Greater Poland, Home Worker - ESP, Italy, Munich, UK - London - Brentford

Posted Date:
Feb

Location:
Any European country would be considered based on GSK's location policy.

As Clinical Quality Assurance Audit Associate Director / Manager, you will provide independent Quality Assurance to GSK R&D by delivering the audit program.

You will also monitor trends, support QA activities during regulatory inspections, collaborate with business function leaders, Risks Managers and Ethics & Compliance Officers and be accountable for driving quality improvements back into R&D Business Functions and improve processes.

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

Independently plan, lead, and conduct routine and complex CQA audits of GSK studies, systems, external vendors and GSK Operating Companies to assure compliance with GCPs and GSK policies and procedures, and applicable local regulations
Effectively document audit findings in an audit report and obtain responses in a timely fashion
Report and present to clinical development staff, clinical investigators and contract research organization staff findings from audits and give advice on resolving issues identified
Generate and provide metrics, status and trend reports and other information, as required by management
Partner with CQA Management to develop, implement and assess clinical quality assurance strategies, organizational and operational needs
Act as a consultant and represent department to clinical development staff and teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment
Maintain an up to date and indepth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to assigned business area processes and procedures
Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility
Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility

_ 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
A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance
Previous experience of Good Clinical Practice (GCP), Good Pharmacovigilance Practice and/or Quality Assurance
Auditing experience in the area related to Good Clinical Practice and/or experience as Clinical Research Associate
Extensive knowledge of global, regional and national regulatory requirements and regulations
High degree of organizational awareness and working towards resolution with complex problems
Excellent verbal, written and presentation skills
Ability and desire for frequent domestic and international travel (approximately 2540%)
Fluent English

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

Demonstrated ability to function effectively and strategically as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively
Detailed knowledge of the drug development and clinical processes
Demonstrated experience interacting with regulatory agencies
Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization

_ Why GSK?_:

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