2024-05-15
AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Waukegan
Illinois
60087
United States
Duration: 12 months contract
Job 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.
Experience:
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 and interpersonal skills.
Education:
Bachelors Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical or scientific area
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Shivangi
Email: shivangi.s@ustechsolutionsinc.com
Internal Id: 24-09578
