Description:

• Oversees the integration and implementation of quality assurance systems and activities across multiple global and regional quality functions.
• Oversees evaluation of quality system processes and procedures from a GMP perspective.
• May lead or participate in the management of integration activities across multiple disciplines including but not limited to Production process controls, suppliers & third parties, quality compliance and quality control.
• Works cross-functionally to ensure quality processes are compliant, efficient, and meet global regulations pertinent to product portfolio.
  
  Responsibilities:
• Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements using appropriate project management tools and processes.
• Manage quality system integration projects within established scope, schedule, and budget. Work cross functionally to drive business integration objectives.
• Ensure effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions.
• Drive integration Quality projects across multiple functions in Operations Quality and the broader operations network; ensure subsystems are connected and cross-system dependencies are optimized/leveraged.
• Drive implementation of harmonized policies, processes and procedures that integrate acquired companies into the quality system across the global network; define clear governance rules to remove redundancy and drive desired outcomes. Collaborate with partners in global and site roles across the network to drive broader network compliance and efficiency.
• Establish and maintain Quality System communications that enable awareness of integration progress for area of responsibility and across multiple workstreams as required.
• Create and maintain robust linkage between quality systems integration and manufacturing and global teams to drive harmonized, compliance and agile processes.
• Lead the collection, verification and reporting of quality system integration metrics for report out to senior leadership.
• Manage quality communication activities in association with Operations communications representatives to ensure the organization is appraised on key quality initiatives
  
  Qualifications:
• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical or scientific area.
• 5-8 years’ experience with quality assurance and/or quality system oversight.
• Leadership of other technical professionals and experience in leading cross-functional teams with results orientation. Skilled in the strategy development, initiation, selection, coordination, and management of projects and have the ability to solve unique problems.
• Knowledge of regulations and standards affecting devices, combination products and Biopharma products.
• Understands impact of changes to quality systems across a diverse network and ability to adjust accordingly.
• Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills a plus.