At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. Our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.
Our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking and act with a sense of urgency. We are courageous, taking risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver medicines.
The 'R&D Quality Assurance Audit team' provides excellence in audit across the R&D operations at AstraZeneca.
As 'Director, QA' based in Gaithersburg, USA you will be the Team Lead for the group of auditors delivering the R&D QA Audit Program for GCP, GVP, Data Integrity and external vendors. You will work alongside a variety of stakeholders inside R&D QA and within the AZ R&D organisation to ensure the effective delivery of audits within the Audit Program. You will work with other senior members of the Audit QA function to maximise audit resource, identify areas to support training and development needs of those within your team. As a senior member of QA, you will form part of the Audit QA Leadership Team, bringing experience and depth of knowledge to help drive audit strategy forwards.
As such the role is varied and provides leadership opportunities across a broad range of disciplines. For example, you will lead and develop individuals within the USA based audit team, ensure delivery of audits performed within the USA team. Also, you will be required to provide expert audit support to more complex or sensitive directed audits. Your experience of managing Regulatory Inspections (e.g. FDA, EMA) will be essential. You will be recognised as a leader in your field and as leader of people.
This role will act as 'site lead' for QA in Gaithersburg, USA and have a dotted reporting line into the QA Leadership Team (QALT). As an extended arm of the QALT, the role will ensure QA staff present in USA have a 'voice' at QA leadership and are strongly supported with local matters.
With that in mind the role is best suited to candidates with a high degree of integrity and strategic thinking agility. It is also important to have a 'solutions focused' attitude and the ability to generate simple solutions to complex challenges. Importantly, you will need to have a proactive 'Business Partnering' mindset and the personal credibility to effectively communicate and establish trust with senior stakeholders and leadership teams across the globe. This is critical to enable you to influence decisions and thereby sustain the Quality Mindset.
Responsible for implementing, resourcing and continuously improving an effective risk-based assurance program
Participates in assurance activities (audits, due diligence, inspection management) and assesses operational execution of processes and audit strategy
Deploys resources to support in-licensing due diligence activity and provides advice on recommendations arising from results as appropriate
Leads or supports the management and preparation for regulatory inspections, including providing pre- inspection training to the organisation as needed.
Provides QA oversight and/or management of regulatory inspections
Accountable for development of assigned staff and achievement of performance standards, capability and effective organizational leadership
Coaches and mentors QA staff
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
Resources Audit and Inspection staff to allocated activities for the successful delivery of audit programs
Contributes to functional budget management
Job Specific General Accountabilities
Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area
Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
Maintains strong business relationship with relevant business stakeholders
Provide effective compliance reporting to senior management and contributes to strategic QA governance forums
Contributes to functional budget management
Quality Assurance General Accountabilities
Ensures own and team's tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
Drives, promote and embeds a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
Communicates effectively with QA colleagues and cross functional business stakeholders at all levels
Maintains knowledge of relevant industry information affecting quality and compliance arena
Leads training for colleagues and business stakeholders as required.
Involved in and may lead the development and/or revision of QA processes, projects and tools
Coaches and mentors QA colleague.
Provides general support related to regulatory authority inspections as and when required
To be successful in this role you will need:
Bachelors' Degree level education
Significant experience in pharmaceuticals or a related industry
Excellent analytical, written and oral communications skills
Fluent in written and spoken English
High ethical standards, trustworthy, operating with absolute discretion
Strong collaborative, influencing and interpersonal skills - curious to understand business environment
Skilled at managing & using technology
Ability to maintain and create professional networks with stakeholders
Experience in managing regulatory health authority Inspections
Demonstrable leadership skills and experience