CQA Audit Manager

仕事内容

Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer.We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. Theseare at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal.You commit to living our values and expectations and performing against our Innovation, Performance and Trustpriorities. In return, GSK commits to providing the right environment for you to thrive.Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively

CQA Audit Manager

About The Role

In this role you will…

• Provide Independent Quality Assurance to GSK R&D, by delivering the audit program including defining scope, conducting audit processes, reporting observations and ensuring receipt and review of CAPA plans.
• 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.
• Build a network of contacts including business function leaders, Risk Managers and Ethics & Compliance Officers.
• Partner 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 process controls, management monitoring and independent business monitoring.
• Maintain knowledge of local regulatory frameworks, and clinical research activity.
  

Key Responsibilities

• 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
• Provide expert 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 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
• 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
• Deputise for manager and take on delegated duties as required
• Support the recruitment of new CQA staff
• Manage/Champion and participate in other projects or duties assigned by the CQA management specific to CQA teams accountabilities.
  

This job opportunity is a permanent contract not opened for relocation.



Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade.

Why you?

Qualifications & Skills

• 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, 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
  

Preferred Qualifications & Skills

• Has demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization
• Have a 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
• 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 excellent verbal, written and presentation skills
• Ability and desire for frequent domestic and international travel (approximately 25-40%)
• Li-GSK
  

GSKTechTalent

Why GSK?

Our values and expectations are 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 in a culture of Innovation, Performance and Trust.

GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our Department

The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.

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 suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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