Process and Standards (P&S) Director Alliance Management

Location: Warsaw, Poland,
Hybrid model of work: 3 days in office, 2 remote per week

The HBSPartnership Management (AM) group sits within Project, Portfolio & Alliances (PPA) in PMBand is accountable for setting the sourcing strategy across R&D and managing adherence to it. They ensure our partners deliver to the needs of the organisation; and develop strong, beneficial partnerships.

The remit of the Process and Standards (P&S)AM is to harmonize, streamline and simplify processes and ways of working acrossR&D stakeholders and partners within our central lab model. The P&S AM will own and lead key areas and processes and drive forward strategic initiatives which requires collaboration with persons of influence and in decision-making positions across AZ and partner organizations.  They will also be responsible for key areas of AM e.g. driving key strategic initiatives for AM and the wider organisation related to outsourcing.

This role will work globally across R&D and alliance managed models/services and outsourced partners to identify, drive and lead improvements to initiatives and business processes, driving value across the business and enabling the strategic partnerships to work efficiently and effectively.  

The incumbent will have the opportunity to lead key areas utilising their knowledge and experience across a variety of areas including: 

• Partner Selection, Qualification & Oversight process;

• Process integration between AZ & Central Lab/Outsourced Partners;

• Quality management;

• Risk & Issue management;

• Strategic reporting, dashboarding & digital/data solutions;

• Coaching & training on new processes/ways of working;

• Inspection readiness for audits & regulatory Inspections;

• Other strategic / continuous improvement initiatives

The role will be responsible for developing strategic plans, driving and leading a variety of key areas/initiatives focused on building improved operational capabilities and accelerating consistent ways of working across the Central lab model, broad stakeholder groups and outsourced partners and will be tasked to lead / manage:  

• Proactively seeking and driving creative and innovative ideas to drive performance and bring new solutions and ways of working across AMand our stakeholders and outsourced partners

• Contribute to / lead large scale complexglobal cross-functional initiatives across HBS Alliance Management, stakeholders and outsourced partners, including planning, project management, change management, training and implementation

• Drive& leadsimplification & standardization of processes, systems and servicesutilized across central lab partners (incl process ownership where applicable)

• Drive & lead an integrated and holistic strategy of outsourced end to end process components for the central lab model; ensure efficient knowledge and use of processes, standards, working instructions, guidance’s, templates and training that provide alignments and efficiencies across outsourced models to include inspection readiness

• Partner Selection, Qualification & Oversight Process ownershipensuring procedural and system documents are developed and/or remediated to reflect new processes and ensure compliance, & adherence and inspection readiness.

• Drive and lead risk/issue management framework / processes and tools are in place and risks & mitigation plans are in place for all models/services and partners; Reports and trends are shared across the central lab model.

• Drive and Lead oversight and reporting of quality related events, trends and insights across the central lab model to drive delivery of central lab Corrective and Preventive Actions to time and quality in conjunction with HBS AM.

• Collaborate with Director of HBS Digitalisation on opportunities for reports, dashboards, and information sharing solutions that provide HBS AM and stakeholder visibility into model/service and partner performance insights; foster a culture that accelerates technology adoption

• Collaborate with Director of HBS Digitalisation to drive & champion data quality, integrity and reliability throughout HBS AM;

• Develop and deliverhigh-quality fit for purpose training materials for new or updated processes, ways of workingand tools, reports, dashboards, and information sharing solutions

• Ensure communication & engagement plans are in place to ensure information/knowledge sharing across HBS AM and internal/external stakeholders in your areas 

• Foster development of a collaborative culture and ensure teams understand that external partners are key to our delivery – and ensure the way we work together will enable success

• Role model partnering behaviours

• Represent HBS Central lab partnershipsand/or lead various networks, governances and forums, as necessary 

• Serve as a delegate for the Head of HBS CLPs for specific tasks or activities, as necessary

• Comprehensive understanding of clinical and pharmaceutical drug development process at various phases of development

• Knowledge of end-to-end central lab processes, including sample management lifecycle, chain of custody, and lab-specific operations.

• Demonstrated ability to foster trust, transparency, and joint accountability with partners, ensuring mutually beneficial outcomes and shared value creation.

• High level knowledge of process development, ICH GCP and related guidelines and practices

• Experience / expertise leading in one or more of the following areas: Process management incl. compliance, Process integration; Quality management; Risk & Issue management; inspection readiness 

• Experience in supporting process improvement initiatives using Lean/Sigma or other business process improvement tools and/or processes

• Knowledge of existing AstraZeneca external partners & models  

• Knowledge of AstraZeneca policies, procedures and guidelines