Senior Template Control Leader

Role Summary

Global Qualification Services delivers documentation and services to global customers which are used for registration of GxP processes and products and research / development / hospital / university.

Essential Responsibilities

The demand for products and services from Qualification Services is increasing double digits year over year and business segment are added to the portfolio on a yealy basis. As a result of an increasing demand of new qualification products we are seeking an Senior Template Control Leader to help drive and lead the work of the Project Office Business. The role is including the need to cooperate with stakeholders across LS multiple functional teams and regions. The business is pointed to several different LS segments.

Interact with QS Operation, Template Management and NPI/CBS/CCP sub business

Manage and control all Technical review and approval in Template and Order/Production phase

Manage template control for all FlexFactory, CBS, NPI and standard qualification offering

Manage all customer complaints to secure Corrective and Preventive action

Communicate current state to senior management and make sure deliverables are met

Manage all customer complaints (using the tools at hand); handle Quality tasks, regional communication to display CAPA actions completed and in progress

Cooperate and communicate with key stakeholders to secure Qualification Services product development

Lead, improve and manage new product introduction within process/team

Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives

Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones

Support communication to wider service organisation on program/project awareness including inputs and involvement in all NPI programs

Qualifications/Requirements

• Ability to communicate with different stakeholders in different regions
• Bachelor’s degree in Science, Engineering or related area with relevant work experience
• Work experience within GxP qualifications within Technical area
• Demonstrated knowledge and experience working with technical writing area
• Demonstrated capability of cross-functional and cross-site interactions and ability to drive project plans to completion
• Ability to develop and execute multiple priorities and approaches to meet objectives

Desired Characteristics

• Experience with entire template development and maintenance flow, procedure and tools
• Familiarity with ISO, GxP and other regulatory standards
• English and Swedish as working languages
• Experience of working in a global environment