Compliance and Inspection Readiness Principal
AstraZeneca Pharmaceuticals LP
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our peopleâ€™s exceptional skills with those of people from all over the globe.
As a Compliance and Inspection Readiness Principal in Gaithersburg, MD, youâ€™ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patientsâ€™ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
Working with the Processes and Partnership (P&P) leads in Processes and Partnership Group in Delivery and Enablement, GRAPSQA, taking responsibility for the management of assigned AstraZeneca-MedImmune projects, processes and partnerships including implementation, communication, compliance, performance and inspection readiness. Accountable to develop relationships across GRAPSQA and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.
Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment.
Working with the P&P leads, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
Manages relationships/partnerships/alliances external to the AZ GRAPSQ function that are essential to delivering AstraZenecaâ€™s pharmacovigilance and regulatory LTO responsibilities
Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to safety and regulatory teams and submissions.
Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a â€œcan doâ€ attitude and innovative approaches.
Contribute to the overall management and oversight of the Pharmacovigilance Quality System.
Develop and maintain a vision and strategy for nominated pharmacovigilance or regulatory processes.
Coordination and ownership of the lifecycle management of nominated processes and partnerships, enabling business continuity and compliance.
Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.
Lead the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
Develop and improve reporting tools and analysis processes and technology.
Performing the monitoring, analysis and trending of data.
Identify issues and risks and propose options to mitigate them.
Monitor, interpret and validate current, new and changing legislation, and manage the impact of changes.
Ensure that appropriate, up-to-date records are maintained for compliance
Participate and /or support activities for GVP, GCP, GRP and GMP audits/inspections
Provide support to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection
Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
Provide process training to GRAPSQA, partners and other functional groups.
Seek personal and professional development opportunities, and share knowledge gained in open forums
May represent AZ on industry bodies
Serve as the delegate, where appropriate, for the P&P Leads
Contribute to communication and change management activities associated with processes and partnering initiatives.
Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships
Participate in development and implementation of strategic outsourcing activities
Education, Qualifications, Skills and Experience
A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
Experience in working cross-functionally
Leadership skills, including proven leadership of project teams experience
Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
Thorough knowledge of the drug development process
Good attention to detail
Excellent written and verbal communication skills
Proven ability to work across cultures
MSC/PhD in scientific discipline
Knowledge of new and developing regulatory and pharmacovigilance expectations
Knowledge of existing AstraZeneca external alliances and collaborative projects
Knowledge of GRAPSQA operating model
Experience of working with third party suppliers.
Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry
Next Steps â€“ Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience â€“ it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Website : https://www.astrazeneca-us.com
At AstraZeneca, we know your health is personal and that’s why we put careful consideration into determining the value and ultimately the cost of our medicines. Many factors go into these decisions such as the benefits our medicines provide to your health and their potential to reduce healthcare spending on other costlier medical procedures. Just as importantly, these decisions enable us to invest in discovering and developing future medicines where new treatments are needed. So how do we balance providing affordable access to our medicines while ensuring their cost reflects the value they deliver to the individual patient and broader healthcare system? We understand the weight of this question. That’s why we spend countless hours not just thinking about it, but finding new ways to help you and those you care about receive the best care possible for medical conditions we focus on. We do this by developing innovative medicines and offering programs that are uniquely tailored to you. We’re also always looking for ways to make your medicines more affordable and we collaborate with stakeholders across the healthcare system in pursuit of this goal.