Job Description:
Pay Range $31.10hr - $36.10hr
Responsibilities: - 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.
Required Qualifications: - 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.
Desired qualifications: - 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.
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Last updated on Sep 14, 2023