Clinical Quality Assurance Manager, Regulatory Inspections and Investigations

You will provide effective management of GCP Regulatory Agency Inspections and Issue Investigations.

You will lead study and functional teams as a subject matter expert for the preparation, conduct and response to GCP Regulatory Inspections.

You will lead cross-functional teams to fully investigate serious compliance concerns, analyze results and agree appropriate and proportional actions to address.

You will also be responsible for monitoring compliance trends from inspections and investigations; and accountable for driving quality system improvements and ensure compliance.

Your responsibilities:

• You support the development, management, and implementation of processes, associated written standards and job aides to support effective management of Regulatory Inspections and Issue Investigations across GSK R&D Development
• You will coordinate and manage Regulatory Inspection activities for GCP process inspections both centrally and at Local Operating Companies. You will serve as the main point of contact for inspection preparation partnering with risk managers to ensure business functions are prepared for both national and local inspections (FDA, EMA, MHRA, etc.). You will ensure identification and mitigation of known quality issues and potential GCP compliance risks. You will lead root cause analysis activities for any inspection findings identified and support the business in development of responses.
• You will support the delivery of Regulatory Inspection activities for clinical programmes in partnership with the applicable CQA Programme Management Lead. You will also provide subject matter expertise to ensure effective inspection management.
• You will provide proactive and regular communication of trends and performance metrics from all investigation and inspection activities across R&D to ensure effective implementation of controls, management monitoring and independent business monitoring.
• You will establish strong working relationships with a network of contacts including clinical project team members, business function leaders, Risk Managers and Ethics & Compliance Officers.
• You will maintain an up to date and in depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to business area processes and procedures. Additionally, you will ensure intelligence is utilised for continuous improvement of inspection management processes.
• You will 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. You will assist in developing and maintaining customer training programmes and help deliver training within area of expertise.
• You will lead local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility.

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.
• 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
• Extensive knowledge of global, regional and national regulatory requirements and regulations
• Detailed knowledge of the drug development and clinical processes
• Demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization
• A demonstrated and sound working knowledge with expert understanding of the approach and perspectives of regulatory agencies
• Demonstrated experience interacting with regulatory agencies

Preferred Qualifications:

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

• The 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

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.As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

• This is a job description to aide in the job posting, but does not include all job evaluation details.

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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