CQA Senior Auditor
GSK
Ciudad de Panama, Panama
hace 5 días

As Clinical Quality Assurance Senior Auditor, you will be responsible for independently planning, leading, and and conduct routine CQA audits of GSK studies, investigator sites, R&D processes , Local Operating Companies (LOCs) snf external vendors. This includes :

Provide Independent Quality Assurance to GSK R&D Central and LOCs , by conducting independent QA audits and assisting CQA management in setting priorities, developing schedules, and tracking of deliverables.

Identify compliance issues, monitor trends, be accountable for driving quality improvements back into R&D Business Functions and improve processes.

Support 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 :

Independently plan, lead, and conduct routine CQA audits of GSK studies, systems, external vendors and GSK Operating Companies to assure compliance with GxPs and GSK policies and procedures, and applicable local regulations

Assist in the planning, and conduct of complex CQA audits

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

Assist 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

Provide advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment and act as point of contact for customers and CQA staff

Maintain an up to date and in depth knowledge of appropriate national and international GxP 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

Assist in developing and maintaining customer training programmes and help deliver training within area of expertise

Work independently and as a member of assigned CQA team

Build and maintain beneficial working relationships with all internal and external customers

Lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility

Manage / Champion and participate in other projects or duties assigned by the CQA management specific to CQA teams accountabilities.

May be responsible for QA support provided to a given business function or region(s). This involves :

Building a network of contacts including business function leaders, Risk Managers and Compliance Officers.

Partnering with these contacts to ensure business function is prepared for regulatory inspections; support and where applicable host local and global inspections.

Proactive and regular communication of trends and performance metrics from QA, audit and inspection activities within the business function and across R&D to ensure effective implementation of level 1 controls, management monitoring and independent business monitoring.

Maintaining knowledge of local regulatory frameworks, and clinical research activity

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

Ability and desire for frequent domestic and international travel (approximately 25-40%)

Fluent English

Preferred Qualifications :

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

Demonstrated ability to function effectively as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively

Must have a high degree of organizational awareness and working towards resolution with complex problems

Have demonstrated project management skills and management of cross-functional activities

Have demonstrated ability for good verbal, written and presentation skills

Previous auditing experience, mainly in the area related to Good Clinical Practice

Knowledge of global, regional and national regulatory requirements and regulations

Knowledge of the drug development and clinical processes

Have a demonstrated and sound working knowledge of the approach and perspectives of regulatory agencies

Demonstrated experience interacting with regulatory agencies

Has demonstrated ability to manage global projects and programs, which can contain regional focus / drivers in a culturally diverse organization

Spanish and / or Portuguese at least intermediate / advanced

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