Overall Purpose of Job

The Quality Manager (QM) will oversee the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) and Quality Metrics performance. The QM will work with management and functional personnel to plan, develop, implement and continually improve relevant QMS policies, standards and procedures, and to ensure sustainable compliance to customer, regulatory and Intl SOS-GMS QMS requirements. In addition, this role shall be responsible for overall development, implementation and maintenance of effective EHS policies, procedures, programs and initiatives that culminate in a culture of sustainable and consistent safe work performance, as well as overall reduction in risk exposure to the enterprise.

Key Responsibilities

• Provides ongoing leadership and support in developing, implementing, maintaining and continually improving the Quality Management System (QMS).
• Ensures that individual contract QMS/QCP’s are in compliance with Intl SOS-GMS QMS requirements, including Quality Metrics reporting.
• Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008, GMP (21 CFR Part 820), Joint Commission, etc., including preparing for and scheduling annual certification compliance audits.
• Informs Management of significant or potentially significant quality issues and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.
• Monitors and measures trends in QMS processes, including GMP Quality Metrics.
• Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008, GMP (21 CFR Part 820), Joint Commission) through internal audits and the evaluation of site Quality Metrics data.
• Collects and submits quality task tracker and quality metrics data for all sites, on a monthly basis, and issues a report to Corporate Management.
• Interacts with customers and assists with quality related responses to RFP’s/RFI’s for the site.

Key Responsibilities

• Develop, implement and lead EHS framework, safety culture and implementation.
• Analyze claims and other data by collecting, monitoring and creating models for decision support.
• Develop all appropriate EHS policies and high-level enterprise objectives to meet or exceed such policies.
• Leads and manages ongoing internal process verification audits throughout year.
• Ensures all deviation investigations are appropriately investigated and recorded.
• Drives CAPA items to comprehensive and timely completion.
• Participates in other activities, as deemed appropriate.

Experience Required

• Minimum 2 years of supervisory experience.
• Advanced training or experience in cGMPs, and ISO required.

Required Knowledge, Skills and Abilities

• Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issues.
• Must be able to prioritize and multi-task with minimal supervision.
• Excellent written and verbal communication skills.
• Minimum of 5 years of experience in developing and managing Quality Management Systems in compliance with ISO 9001, preferably in a medical services environment.
• Experience in writing procedures in support of ISO 9001 compliance.
• Experience in auditing, process analysis, process mapping, root cause investigation, document management and record keeping.
• Proficient project management skills.
• Strong interpersonal, leadership, analytical and problem-solving skills.
• Expert knowledge of computers and MS Office platform (e.g., Word, Excel, PowerPoint).

Education Required

Bachelor's degree, with a minimum of 5 years in relatable work experience required.

Physical Requirements

• Physically capable of performing duties and responsibilities as listed above.
• Sitting for prolonged periods of time.
• Frequent use of common office technology such as the computer, telephone etc.
• Ability to lift, carry and move up to 30 lbs.

Travel

Up to 35%

Additional Information

This job description outlines the types of responsibilities the incumbent is required to perform.

The incumbent may be required to perform job related tasks other than those specifically presented in this job description. This job description is subject to regular review.