3 years + in IT Quality and/or Compliance in a global role
Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
Strong communication, influencing and relationship building skills
Strong change leadership and team working skills
Proven ability to analyse highly complex situations, assessing risks and balancing strategic and tactical security/compliance/quality requirements with business pragmatism
Strong knowledge of global Pharmaceutical Regulations (FDA, Annex 11, Sarbanes Oxley, etc.)
Knowledge of industry good practice and standards such as GxP, CMMI, SPI, GAMP, ITIL, COBIT, Risk Management
An ability to work effectively in a matrix organization is essential
A self-starter with high levels of drive, energy, resilience and a desire for professional excellence
Ability to drive change and performance in supplier and internal AZ IT functions.
Ability to analyse requests or issues and provide the best possible solution
Ability to prioritise, re-schedule or adapt to changes
Ability to communicate both written and orally at all levels of the organization and be able to work with offshore service personnel
Ability to make decisions in pressure situations at a management level
Proven ability to interpret and communicate technical information into business language
Strong compliance experience/expertise
Job Dimensions Review the standard role profile and capture the specific resource management accountabilities required in the role $ &/or People; key relationship.
Direct reports - none
Budget responsibility - none
The Quality & Compliance group in the Infrastructure and Operations function is responsible for establishing global IT Compliance and Risk Strategy, relevant policies, standards and risk appetite in alignment with corporate risk direction
Delivery/execution teams are distributed across IT/Business functions. Deployed resources and processes to business areas are based on demand. Resources report directly into the IT Quality and Compliance group
The IT Quality & Compliance team is global in scale
Ensure there are no operational compliance-related issues within their aligned area by providing independent assurance and oversight of processes and controls.
Identify, communicate and manage compliance risks, breaches and issues, and monitor corrective action to mitigate the risk
Own and embed compliance issue management processes within their area ensuring that organisational and supplier compliance issues are identified, assessed, and resolved in support of AZ's license to operate
Support critical SET governance by providing quality and compliance input throughout end-to-end process
Deliver independent assessments of assurance and compliance activities e.g. GXP, SOx, proceses.
Manage and deliver on compliance assurance improvement plans within their defined area.
Work with service delivery teams/suppliers to ensure they have appropriate resources available to support inspections and liaise with other appropriate Q&C teams to enable this to happen
Point of contact for SOx matters within their aligned area
Provide QC consultancy support to Service management and third party activities