Regional Qa Systems Lead Aprilia

Regional Qa Systems Lead
Aprilia
Lazio, Aprilia

Company Description

We are now looking for a Regional QA Systems Lead to join our team on a fixed term contract.

Optimise and improve Quality Systems (QS) performance within and across Regional Operations activities.

The individual leads communication planning, preparation and actions to ensure improvements are harmonized and shared across the manufacturing network and the quality system documents and IT systems are aligned accordingly.

**Responsibilities**:

- Drive critical Quality projects across multiple sites across various countries; ensure subsystems are connected and cross-system dependencies are optimized to deliver measurable compliance performance improvements.

- Define clear governance rules to remove QS redundancy and drive global alignment of the Abbvie Quality System.

- Participation in EU QMR, and Quality Business Reviews supporting EU Regional VP with activities including trend analysis, regional quality plan execution, support of operations sites quality projects.

- Collaborate with partners (QA, Manufacturing, Engineering, Supply Chain etc. )

in global and area roles across regions to drive broader network efficiency, effectiveness and alignment.

Coordinate and actively manage relationships & agreements with key Third Party Manufacturers/Customers appropriate to the Region

- Development, alignment, improvement and implementation of key Quality System processes and procedures, is the owner of QPP01, Production & Process Control global policy and leads that important Centre of Excellence group.

- Develop and drive Regional specific QA focused teams to deliver measurable improvement initiatives.

Develop policies, processes and procedures that harmonize the quality system across the network;

- Define and implement a Regional QA project management governance to ensure clear communication of milestones and progress of Regional projects.

- Ensure the Quality System is current, compliant and adhered to across the AbbVie manufacturing network

- Create and maintain robust linkage between QA Systems and Regulatory Intelligence/Knowledge Management resulting in no significant inspectional observations relating to Quality Systems.

- Lead the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local / global project implementation.

- Management of HIV Product QA including supporting sites on significant events, approve global changes, assess complaints, regulatory documentation, drug shortage prevention plans and acting as the quality representation for strategic initiatives related to the product

**Qualifications

- Bachelor's degree in a relevant field and 10+ years experience and proven knowledge and experience within the Quality organisation with experience working within & leading key COE projects

- Proven communicator of both tactical and strategic programs.

- Strong manufacturing/plant experience ideally stemming from within Regional experience.

- Successful track record of delivering results in complex projects and programs; proven leader of direct reports as well as of matrix teams.

- Experience working and delivering results across multiple sites/geographies.

Preferred experiences: change management, AbbVie Operations, financial planning processes.

- Ability to travel up to 35% within and across Regions, as require

Local grades differ depending on the location and may differ to posted grade.

**Additional Information