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Vice President, R&D Quality Assurance, Clinical Trial Transparency and Clinical Policy

Location Gaithersburg, Maryland, United States Baar, Canton of Zug, Switzerland Dublin, Leinster, Ireland Gothenburg, Västra Götaland County, Sweden Job ID R-190858 Date posted 07/02/2024

Help push the boundaries of science to deliver life-changing medicines to patients! With science at its heart, this is where breakthroughs born in the lab become transformative medicine – for the world’s most complex diseases. Striving to understand the needs of diverse populations and act accordingly, we aim to transform healthcare to secure a future where everyone can access affordable, sustainable, innovative healthcare. Answering unmet needs by pioneering the next wave of science and targeting the drivers of disease to help us create the next generation of therapeutics.

With our ground-breaking pipeline, the outlook is bright. Be proud to take your place somewhere that has already achieved so much and is determined to do more. There is no better time to join our global, growing enterprise as we lead the way for healthcare and society

Join AstraZeneca as a Vice President of R&D Quality Assurance, Clinical Trial Transparency and Clinical Policy. This role offers the opportunity to establish direction and provide strategic leadership to multiple teams. You will be accountable for the design and compliance of our Quality Management System and framework to relevant regulatory requirements. This role is a chance to lead global teams and support staff, and manage relationships with regulators, industry groups, and external advisers.

Responsibilities

  • Lead groups and develop and sustain high-quality organizations that develops and delivers against global processes, and strives to continuously improve in competence, scientific standards and innovation and performance
  • Provides assurance across R&D and proactively partners with stakeholders to share data-driven insights, advice and expertise with the strive to embed a quality mindset and a culture of ethics and integrity
  • Lead the Quality Review Board activities
  • Supervise the design, conduct and reporting of a fit-for-purpose second line risk based audit program to provide assurance of compliance with GLP, GCP, GVP, Lab GCP, GLS and HBS
  • Accountable for the performance and quality of the clinical transparency processes in scope.
  • Provides effective management and escalation of quality incidents and CAPA and provides adequate KPIs / measures to stakeholders, in order to set the direction of quality.
  • Ensures successful conduct of major health authority inspections
  • Leads the work on developing, improving, maintaining and making accessible, a modern and fit-for purpose Quality Management System for R&D.
  • Manage headcount numbers and costs to budgetary targets agreed with the Chief Medical Officer
  • Maintains a current understanding of relevant laws, regulations, and self-regulatory standards and developments and ensures AZ programs evolve to respond effectively to changing government and societal expectations.
  • Line Management activities:
  • Accountable for development of assigned staff and achievement of performance standards, capability and effective organizational leadership
  • Optimise the business performance of direct reports to ensure an effective QA organization
  • Ensuring own and staff member tasks are performed to current practices and in accordance to company standards and ethics
  • Contributes to functional budget management

Minimum Requirements

  • Bachelors Degree required, with preferred Pharmaceutical/Scientific qualification and postgraduate training or equivalent
  • Extensive experience from pharmaceutical industry, including at least 5 years in Quality Development with a record of professional achievement and recognition within multiple areas of Pharmaceutical drug development
  • A broad understanding of the technical/regulatory requirements within drug development and an ability to balance this with industry standards to achieve business goals
  • Proven leadership and senior line management in the pharmaceutical industry
  • Extensive industry experience and established networks and acknowledged as a quality assurance expert internally and externally.
  • Proven excellent communication skills and experience of leading teams from different national cultures
  • Successful management in leading change processes
  • Proven track record to influence whilst maintaining independent and objective views

Skills and Capabilities

  • A broad and comprehensive understanding of pharma industry related requirements and how they translate to robust compliant and efficient standards
  • Awareness of the latest developments and interpretations by regulators and industry peers
  • Experience in working with external providers, collaborators, e.g. from academia and other Pharmaceutical companies
  • Ability to resolve conflict and deal with a wide range of sophisticated problems independently where highly-developed analytical skills, conceptual thinking and strategic vision are required, thus representing the highest level of business risk management
  • Attention to items that matter – passion for simplifications and continuous improvements to support integration of quality as an enabler to reach the company ambition
  • Ability to initiate and sponsor improvement projects within AZ to drive the quality culture across R&D enterprise
  • Excellent interpersonal skills that influence and craft the image of the organisation internally
  • Strong networking and influencing skills with world-leading medical and scientific experts in relevant areas and with internal key stakeholders
  • High degree of autonomy and integrity

Are you ready to make a difference? Join us and be part of a team that is looking to deliver life-changing medicines and truly improving patient outcomes. Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

50300057 K CPSC

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.