Associate Director, Quality Strategic Ventures

This is what you will do:

This position will report to the Sr Director, Quality Strategic Ventures (QSV)and Risk Management and will focus on complex Quality projects related to integration and transition of external and internal assets impacting the Alexion Quality Management System (QMS) and GxP Partners (including R&D, Operations, IT, others). In addition, this role will be responsible a variety of functional strategy-related initiatives and ensures the successful development and execution of project plans related to cross-functional programs, key department projects, remediation and process improvement projects. The Associate Director, is an expert in the drug development process, GxP regulations and their application, and has previously led cross-functional teams through complex projects. The Associate Director establishes and maintains productive relationships with cross-functional colleagues, prioritizes listening and can influence and motivate team members without a reporting line relationship. The Associate Director will assist in risk identification and proactive mitigation strategies during business development and due diligence activities and coordinate updates in the QSV Playbook.  In QSV we deliver complex, strategic projects that foster the advancement of Alexion’s Quality organization and business priorities, creating tangible benefits for Patients, Colleagues and Shareholders. QSV is part of Central Quality Systems and Compliance (CQSC).

You will be responsible for:

• Serving as a broad Quality expert willing to work with many different individuals, stakeholders, and sub-teams.
• Managing cross-functional teams across Quality to deliver the project goals and timelines and ensure compliance while leveraging support from a project manager. Lead projects composed of matrixed resources and teammates at varying levels and experience.  Lead through peer influence and effective collaboration skills.
• Utilizing knowledge of GxPs (GLP, GCP, GMP, GDP) and knowledge of the Alexion/AstraZeneca organization to engage the right SMEs on every project at the right time.
• Negotiating project timelines with cross-functional partners (AstraZeneca partners, Alliance Management, IT, R&D, Operations, Commercial) to ensure GxP compliance while meeting the needs of the business objectives.
• Appropriately applying project management tools to ensure successful project delivery.
• Identify, prioritize, facilitate, resolve and appropriately escalate and communicate project risks and issues as they are encountered.
• Planning and scoping GxP change control strategy in an efficient way with team and SME support.
• Providing routine and ad hoc project updates to teammates, Managers, Senior Leaders, and other stakeholders tailored to the appropriate audience and level of detail.
• Assist in the development and maintenance of Quality Project Plans (QPPs) to articulate and guide the strategy of complex projects; author Quality Reports to close out projects. Ensure GxP-related project records are fully retrievable in the QMS for inspection purposes.
• Assist in the facilitation of lessons learned reviews on QSV projects and assist in the maintenance of the QSV Playbook per new business needs and the lessons learned.
• Assist in the facilitation of cross-functional Quality due diligence teams and deal planning teams to ensure proactive risk identification, prioritization and mitigation for incoming assets and companies.
• Ensuring Quality risks are considered in due diligence efforts and articulated to Alliance Management/business development teams.
• Supporting Quality Risk Management initiatives, outreach to customers, and risk facilitation as needed.

You will need to have:

• Bachelor’s degree in a life sciences, engineering, or scientific discipline
• 10+ years of experience working in a regulated (GxP) Quality role
• Broad understanding of GxP regulations and their application in drug development and commercialization
• Proven track record of planning and managing complex projects with demanding timelines
• Excellent communication including written skills and verbal presentations
• Strong project management skills including planning and organizing
• Excellent relationship-building and stakeholder-management skills across all levels
• Demonstrated ability to work autonomously and within a team
• Demonstrated ability to prioritize workloads through effective decision making
• Broad understanding of Quality Management System operational aspects and design elements in a Biotech/Pharmaceutical setting.
• Ability to work collaboratively, raise issues in a productive way, and reach consensus in cross-functional settings, in remote work settings, across global cultures.
• Ability to leverage change control and document management systems for GxP records management.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Advanced degree (Ph.D., MBA or Masters) a plus.
• PMP or Six Sigma Certificate a plus.
• Expert use of Smartsheet Project Management Tools, or similar tools and the ability to rapidly learn.
• Experience supporting company or asset integrations in the life sciences, pharma or biotech fields.

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.