ABOUT ASTRAZENECA

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 explore innovations and confront challenges that others won't, in order to have a greater impact on patients' lives.

As a global science-led biopharmaceutical company, everything we do comes back to improving the health of our patients worldwide. We seek out new opportunities to do dynamic and significant work, and we encourage our people to continually foster new insights to find different ways of building ground-breaking medicines. This is why, today, we have an unparalleled product portfolio in Oncology, Respiratory and Cardio-Renal Metabolic diseases.

ABOUT THE ROLE

The Associate Director, Clinical Systems Quality is responsible for supporting the delivery of Quality Management activities, with a focus on technologies, used in clinical development within R&D.  The role works with stakeholders across the business  to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Development Operations and other Clinical R&D functions.

Main Duties and Responsibilities:

• Establish and maintain effective systems and processes to support key performance areas for CQC to maintain Quality Management excellence

• Collaborate effectively with colleagues and stakeholders to support quality and compliance related initiatives/activities and act as a quality champion advocating a culture of quality across R&D. 

• Provide Quality and Compliance advice and best practice guidance on clinical development related technology.

• Engage in advisory guidance for quality events, initiatives and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes)

• Assist functional representatives as they prepare for regulatory inspections (where necessary)

• Coordination of defined GCP systems audits and advising where necessary on other audit outcomes (responses, CAPAs, lessons learned)

• Support identification and management of quality risks, including mitigation of risks and communication of significant risks to management

• Participate in any assigned operational committees and provide clinical quality expertise to external partners

• Actively participate in internal and external quality groups and fora sharing relevant information, experience/knowledge and best practices.

• Support CQC  Leadership in the strategic direction and priorities of the group. Contribute to CQC objectives and strategies that drive a culture of quality.

• Maintain current knowledge and awareness of  regulations / guidance as well as any internal processes pertaining to clinical trials;  provide interpretations of regulations and assessing impact on our systems and providing recommendations, where necessary.

• Conduct Quality Reviews for key validation documentation based on a risk-based approach

Education, Qualifications, Skills and Experience

Essential

• University degree in related discipline, preferably in life science or equivalent. Higher degree in a scientific or business discipline is desirable

• In depth demonstrable experience in a clinical compliance or quality related position with a track record of success in managing quality and compliance activities

• Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements.

• Highly developed problem solving skills and the ability to resolve difficult conflicts

• Strong interpersonal and communication skills with the ability to influence others.

• Ability to multitask and to work efficiently and independently under pressure.

Desirable

• Experience in computer system/technology validation for medical devices, software as a medical device or artificial intelligence/machine learning

• Demonstrated project management skills

• Ability to motivate a team and work effectively within a team in a fast-paced, ever-changing environment

• Strategic thinking and planning

• Conceptual thinking

• Negotiation and influencing skills

• Ability to manage change

• Coaching and mentoring

• Strong ability to work independently

• High ethical standards, trustworthy, operating with absolute discretion

What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, company car or car allowance, lunch card, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), Multisport, anniversary awards, additional time off, pension plan, business travel insurance, recognition programme, flexible working hours.

Apply today and find out more!

Date Posted

Closing Date

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.