This is what you will do:The Associate Director, Quality Business Development Lead, is responsible to establish the Quality Operations strategy and complete the planning and execution of integrations for new commercial assets, company acquisitions and partnerships between Alexion and parent company AstraZeneca.This is a leadership role, acting as the Operations Quality principle point of contact and cross-functional team member to the Business Development & Integration team and other Alexion & AstraZeneca teams.
The role is accountable to complete pre-acquisition due-diligence, integration impact assessment and establish the Operations Quality integration strategy, including organizational capabilities.
The role will also develop the Operations Quality integration plan, and co-ordinate the successful and complete execution of Operations Quality integration activities.
The position serves as a point of escalation for Operations Quality asset integration activities and risks.
Where required, the role owns the Product Quality Lead actions and programs prior to the transition of the asset to the business-as-usual oversight of the Operations Quality team.The role will be accountable for the Quality integration programs, including establishing and coordinating Quality cross-functional project teams.You will be responsible for:Act as the Operations Quality Lead and primary point of contact in Business Development and Integration Governance.
Accountable for the Operations Quality Due Diligence activities for potential new Assets, Asset integrations, company acquisitions and partnerships.
Ensure consistent and complete assessment of the asset quality operations processes pre-acquisition.
This includes gap and risk assessments of the quality processes for GMP manufacturing, control strategies, testing, release, regulatory filings, and other quality and compliance aspects as required.Establish the strategy for asset integration into Alexion Operations Quality.
This includes mapping operational capabilities, establishing the knowledge transfer roadmap, designing the future operating model, aligning ways of working, designing the integration of quality processes and control strategies, developing risk mitigation strategies and leading asset scenario and lifecycle planning.Partner with Central Quality teams to provide input into the organizational integration plans and ensure the seamless integration of the Quality Management System.Partner with Regulatory teams to ensure successful dossier preparation, review, and submission.Lead the asset integration project for Operations Quality.
Develop the asset integration plan, identify risks and mitigations, timelines, resources and budget and establish and lead cross-functional Quality teams to execute the integration plan and handover activities for business-as-usual operations.Act as the point of escalation for Operations Quality, partnering with the relevant senior leaders, steering committees, and Business Development project teams to resolve issues and risks.Provide updates to Operations senior leadership on progress and risks.Lead the change management process for integration into Operations Quality.Establish the Quality budget and resource forecast for asset on-boarding, commercialization, and business as usual costs and ensure inclusion in the budget planning process.Review and approve Quality Project Plans for each integration identifying required tasks needed to complete the asset integration, company acquisition or partnership.
Post-deal close, complete relevant quality records (e.g., global / local change controls) to manage the activities required to integrate the asset / company / partnership into business-as-usual Product Quality Functions and the Alexion QMS.
As Quality Lead, partner with AstraZeneca colleagues to complete integration activities into AZ, as required.Lead Quality lessons learned activities for integrations to streamline and improve the integration process.
Partner with Business Development leaders to translate lessons learned into improved ways-of-working for future asset programs.Establish and oversee market registration & launch process for Operations Quality.
You will need to have:B.Sc.
degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
>8 years' cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial.Understanding of pharmaceutical bulk and drug product development and manufacturing.Knowledge of quality management systems and regulatory requirements.Demonstrated ability to understand and solve complex scenarios, and make appropriate, risk-based decisions.Proven ability to collaborate effectively and sensitively across all levels of the organization, including senior leadership and external partners.Demonstrated success leading high impact business cases, implementing significant change management programs, and applying technical expertise to complex problems.Experience developing Quality strategies, operating models, capabilities planning.management.Collaborate, negotiate, influence and lead in a matrix organization.Flexibility to travel in support of the role.We would prefer for you to have:Experience with completing acquisitions, partnerships or asset integrations.Project management experience is highly desirable.Understanding of and applying Operational/Business excellence methodologies to develop and optimize Quality processes.Experience in liaising with review and inspection divisions of health authorities e.g.
; FDA, EMA,CFDA and PMDA.Experience in establishing and improving quality systems is highly desirable.Experience preparing budget submissions and business cases is an advantage.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; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.Date Posted20-Sep-2024Closing Date03-Oct-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.