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
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%)
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
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities :
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution.
Now, we're making the biggestchanges we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022 : New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience;
and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact;
stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture.
A culturethat is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership ofgoals and support to succeed;
and where we do the right thing . So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey.
Join our challenge to get Ahead Together.
This is a job description to aide in the job posting, but does not include all job evaluation details.
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