Are you interested in a regulatory affairs role that allows you to accelerate regulatory compliance across the business? If so, this Regulatory Compliance Manager could be an ideal opportunity to explore.Job Purpose:
Deliver independent quality oversight and management to GSK R&D; as a valued partner acting as the single point of accountability for one or more clinical development projects/programmes.
Ensure delivery of an effective independent audit programme that provides assurance that clinical trial activities governed by GCP and related regulations undertaken by and/or on behalf of GSK are compliant with relevant international regulatory agency regulations / guidelines, GSK policies / procedures, and are conducted in accordance with accepted principles for clinical trial research.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Implement and manage the QA audit programme for one or more clinical development projects/programmes ; partner with clinical teams to ensure appropriate risk prioritisation, scheduling, and tracking of QA audits. Provide active support during root cause analysis and support CAPA development
- Implement and manage Quality Assurance Plans for all programmes where audit activities are performed.
- Generate compliance statements for the Clinical study report where audit activities have been performed as requested by the clinical teams
- Provide support to CQA RII in the co-ordination and management of Regulatory Inspection activities for applicable clinical programmes. Serve as the main point of contact for inspection preparation partnering with risk managers to ensure business function is prepared for both national and local inspections (FDA, EMA, MHRA, etc.). Ensure identification and mitigation of known quality issues and potential GCP compliance risks. Provide support in the root cause analysis activities for any inspection findings identified and support the business in development of responses
- Coordinate, manage and/or lead investigations of significant quality issues, support root cause analysis activities and ensure subsequent corrective and preventative actions provide necessary remediation. Ensure appropriate escalation as per GSK global policies and processes.
- Provide proactive and regular communication of trends, risk identification, analysis and performance metrics from QA audit and all investigation and inspection activities within the business function and across R&D to ensure effective implementation of controls, management monitoring and independent business monitoring
- Establish strong working relationships with a network of contacts including clinical project team members, business function leaders, Risk Managers and Ethics & Compliance Officers
- Maintain an up to date and in depth knowledge of appropriate national and international GCP legislation, regulation 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.
- Support local and international GxP and process improvement projects by providing CQA input, especially on areas of responsibility and/or expertise. Assist business Capability Groups in developing and maintaining customer training programmes and help deliver training within area of expertise
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
- Experience with drug development and clinical processes
- Demonstrated experience managing global projects and programs, which can contain regional focus/drivers in a culturally diverse organization
- Experience of the approach and perspectives of regulatory agencies
- Demonstrated experience interacting with regulatory agencies
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, prioritisation and management of cross-functional activities
- Have demonstrated ability for excellent verbal, written and presentation skills
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:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
- 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.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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