What are the responsibilities and job description for the Director, Quality Assurance position at Sharp Corporation?
SUMMARY :
The Director, Quality Assurance, is responsible for leading and overseeing the Quality function at a US Commercial Sharp Packaging site. This role involves the development and implementation of quality strategies and processes to ensure compliance with regulatory requirements and internal standards. The Director of Quality will lead the quality assurance team and will collaborate with various internal departments and stakeholders to foster a culture of quality throughout the organization.
As a CDMO, the Quality Assurance Director will collaborate with clients to understand clients' needs, to report on quality performance and to satisfy them by delivering a consistently high standard of product quality.
This position reports directly to the VP of Quality, US Commercial Packaging.
ESSENTIAL DUTIES AND RESPONSIBILITIES :
The following is a list of minimum responsibilities related to the Director, Quality Assurance position. Other duties may also be assigned.
- Develop and implement quality policies, systems, processes in compliance with FDA, EMA and other regulatory agencies, as appropriate.
- Lead and mentor the Quality team, providing guidance and support to enhance their skills and performance.
- Oversee the management of quality audits and regulatory inspections, ensuring that any findings are addressed promptly and effectively.
- Oversee a robust batch release process and a comprehensive process for quality oversight of manufacturing and quality control.
- Collaborate with R&D, Manufacturing, Quality Control, Technical Operations, Project Management departments to ensure that quality is integrated into all aspects of product development and production.
- Monitor and report upon quality metrics, trends and other significant issues, to senior management, providing recommendations for continuous improvement.
- Ensure that all quality documentation is maintained accurately and in accordance with regulatory requirements.
- Manage risk assessments and develop risk mitigation strategies related to product quality and compliance.
- Responsible for coordinating appropriate problem-solving initiatives to address customer or regulatory quality issues.
- Stay current on industry trends, regulatory changes, and best practices in quality assurance.
- Responsible for coordinating appropriate problem-solving initiatives to address customer or regulatory quality issues.
QUALIFICATIONS :
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES :
Direct supervision of the quality organization at a US Commercial Sharp Packaging site.
PREFERRED / REQUIRED EDUCATION and / or EXPERIENCE :
PHYSICAL DEMANDS :
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and / or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.
Travel to customers and between sites on an as needed basis.
DISCLAIMER :
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
