AstraZeneca is a global, science-driven biopharmaceutical company with a pipeline of exciting new medicines with an array of modalities. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients.

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!

The Associate Director role in Development Quality is a key role in ensuring that License to Operate is maintained in the Development functions and that GMP standards ensure patient safety throughout the progression of the AZ project portfolio.

As the Site AD in the Team Lead role, you will set the standards for yourself and for the Development Quality employees regarding Quality Leadership to ensure that Development Quality is an influential, proactive and valuable partner in the broader development organization.

You will be operating independently on a global and local level in AZ with minimal supervision. We are responsible for compliance decisions having a major impact on AZ development projects globally and therefore AZ’s business and external reputation. These decisions are made against a background of regulations that vary depending on the stage of development and against a set of standards that are often ambiguous.

Holder of Manufacturing License

Holder of the Investigational Medicinal Products regulatory license for the site and accountable for interactions with the Regulatory Authority and maintaining the operational aspects of this license.

Main Responsibilities:

• Develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to Site Quality.
• In collaboration with the Director, Site Quality, ensure sufficient resource/capability to support Site Quality operational delivery.
• As part of the Extended Leadership team, work with the Quality Directors to develop and implement global objectives.
• Owner of PT&D/Pharm Sci QA Business Partner Process, Contact Point, Equipment and facility validation, and lead continual improvement of this process ensuring effectiveness, business efficiency and compliance with GMP regulations.
• Partner closely with the site leadership team to set strategic direction for quality within that area, maintaining quality oversight and assurance of appropriate standards, and driving continuous improvement
• Ensure appropriate Quality input to major Site Quality business improvement projects and may lead projects across the Development functions.
• Responsible for QA review, approval, and Quality operational oversight of internal manufacturing documentation, defining and agreeing on the follow up of corrective and preventative actions from changes and deviations during manufacture.
• Own the delivery of QA activities for their assigned portfolio of projects. Accountable for aligning all QA activities across a project and empowered to resolve any project quality issues across the QA sections.
• Lead PAI preparations in Site Quality to assure the integrity of data and readiness for inspection.
• Owner and approver of Site Quality GMP documentation.
• Support a strong lean culture that promotes standardization, simplification and continuous improvement

Line Management

• Ensure that their own team is effectively organized, resourced and directed to deliver the accountabilities of the team.
• Ensure competence and skills (both technical and soft skills) in team are sufficient to meet the needs.
• Coach, develop and inspire people reporting to them, or broader among all staff in Development Quality, to enhance individual and team performance.
• Ensure that efficient and appropriate working processes and systems are in place in the own team and champion continuous improvement of working practices.
• Deliver against agreed financial and headcount targets

Minimum Requirements:

• Bachelors degree in appropriate scientific field
• 5-10 years of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organization.
• Extensive experience from working in a Quality Assurance function is essential
• A broad and comprehensive understanding of Quality Systems and GMP
• An all-inclusive understanding of the pharmaceutical/drug development process
• Working knowledge and experience in the development and manufacture of inhaled products
• Understanding of Project Management and Supply Chain processes
• Proven Leadership in Quality (e.g. leadership of IMTs and significant quality projects with demonstrable global & cross functional business impact)

Skills and Capabilities:

• Excellent team working and networking skills and encourages team effectiveness
• Demonstrates independent judgement and uses risk management in complex situations
• Capable of making decisions, acting courageously and communicating with conviction and inspiration
• Demands excellence (sets high bar) and delivers
• Builds excellent relationships both internally and with external suppliers or service providers
• Demonstrates drive and energy in the role to make a difference.

Apply Now!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – 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.

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.