Quality Specialist

• This role provides leadership for certain service elements for Commercial Quality to support a rapidly changing business with complex and diverse product lines.
• Primary services in scope include:
• Quality Operations support for the Regional Transportation Organization and the IRTE organization executing in NA.
• Ensuring compliant regional execution and implementation of transportation lane mapping studies, mode qualifications, and temperature control systems related to transportation (e.g. monitoring).
• Quality Operations support the customer service organizations in the region.
• Providing Transportation and Temperature Control supplier quality management services in accordance with standard purchasing control procedures.
• Interfacing with Regional delivery operations to provide a consolidated Quality Review, Metrics, and Reporting for the services in scope.
• Ensures robust performance and continuous improvement of the supplier quality program.
• Responsible for strategic aspects of regional supplier management.
• Influences and drives improvement in supplier performance through engagement at quarterly business reviews.
• Implements programs and projects to achieve cost improvement targets.
• Develop and manage relationships with internal and external trade and regulatory organizations as appropriate.
• Leads and supports activities in the areas of Audit and Inspection, Change Control, NC/CAPA, Root Cause.
• Analysis, and Documentation Control.

• A minimum of a Bachelor's degree; a focused degree in Engineering, Life Science, Physical Science, or related subject area or equivalent years of experience is preferred.
• Minimum of 6 years overall experience.
• Previous experience in Quality (preferably the fields of Quality Engineering or Quality Systems and Compliance within a regulated industry) in the Pharmaceutical, Medical Device, OTC Drug and Cosmetic production environment.
• Knowledge of applicable US and international regulatory requirements for design, development, manufacture, and post-market surveillance and field actions.
• A solid understanding of FDA 21 CFR Part 210, 211, IS0 9001, 820, and/or ISO 13485 and ERP systems.
• A working knowledge of INV/CAPA, Change Control, and General Quality Systems processes.
• Prior experience in Supplier Quality.
• Strong communication, teamwork, problem-solving, decision-making, data analysis, inductive reasoning, critical thinking, and root cause analysis skills.
• Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision.
• Prior experience preparing and presenting written and verbal reports to upper management and business unit heads pertaining to metrics and audit findings.
• Ability to work effectively on cross-functional teams.

• Experience with Quality System IT platforms (e.g. EtQ, PRISM, QLIK, QEM, tru Vault, Compliance Wire, Summit, DMS, LMS).
• Experience working with virtual teams and teams across multiple locations and countries.
• Strong influencing skills.
• Being comfortable and effective at communicating with Leadership.
• Must be able to work independently as well as on teams, with the flexibility to handle complexity and multiple initiatives.
• E2E Mindset with the ability to execute locally/regionally.

Last updated on Sep 14, 2023