Director, Quality at Concentra

Addison, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Apr, 26

Salary

0.0

Posted On

20 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, FDA Compliance, Quality Assurance, Quality Control, Regulatory Inspections, Audits, CAPA, Training, Problem Solving, Customer Service, Attention to Detail, Leadership, cGMP Requirements, Document Control, Change Control, Multi-tasking

Industry

Hospitals and Health Care

Description

Overview Concentra is recognized as the nation’s leading occupational health care company. With more than 40 years of experience, Concentra is dedicated to our mission to improve the health of America’s workforce, one patient at a time. With a wide range of services and proactive approaches to care, Concentra colleagues provide exceptional service to employers and exceptional care to their employees. The Director of Quality at St. Mary’s Medical Park Pharmacy (Concentra) leads all quality assurance/control for the repackaging/relabeling department to ensure FDA 211 cGMP compliance by managing St. Mary’s Quality Management Systems, audits, investigations (CAPA, Deviations), training, and teams, driving continuous improvement, and overseeing product release/disposition to guarantee product safety and efficacy. This position will report to and work with Concentra’s Vice President of Compliance to ensure the Concentra’s corporate compliance initiatives align with St. Mary’s Quality System. Responsibilities Develop, implement, and maintain Quality Management Systems (QMS) for FDA 211 cGMP compliance, including SOPs, document control, and change control Lead, mentor, and develop QA/QC teams, fostering a culture of quality and accountability Ensure readiness for regulatory inspections (FDA, etc.), manage internal/external audits, and oversee supplier quality Ensure identity, purity, strength and quality of the drug product and ensures that no errors have occurred, and if errors have occurred, they have been fully investigated dispositioned, and appropriate and effective Corrective and Preventive Action (CAPA) accomplished Ensure that all complaints, deviations and any other significant issues are fully investigated and reported to St. Mary’s management as well as Concentra’s Compliance Department Maintain and ensure that robust policies and procedures are in place such that the Quality Control lead and team have the knowledge, expertise, and the authority to accept or reject all products and documentation that they review Responsible for a weekly reporting to management, chairing the quarterly Quality Unit meeting, and organizing/conducting annual management quality review/training meeting Oversee quality training and internal audits of the quality system Collaborate with contracted FDA cGMP compliance consultants to maintain FDA 211 Compliance Qualifications Bachelor’s degree from an accredited college or university or equivalent education and experience In lieu of higher education, the ratio is 1:1 meaning one year of college equals one year of work experience and vice-versa. Customarily has at least 5 years of experience in a Quality Assurance or Quality Control position or 2 years in management at a workplace that was responsible for maintaining FDA 211 cGMP compliance Concentra Core Competencies of Service Mentality, Attention to Detail, Sense of Urgency, Initiative and Flexibility Ability to make decisions or solve problems by using logic to identify key facts, explore alternatives, and propose quality solutions Outstanding customer service skills as well as the ability to deal with people in a manner which shows tact and professionalism The ability to properly handle sensitive and confidential information (including HIPAA and PHI) in accordance with federal and state laws and company policies Ability to make decisions or solve problems by using logic to identify key facts, explore alternatives, and propose quality solutions. Ability to work independently within guidelines and company policies. Ability to lead and supervise people. Ability to lead the department Quality team. Working knowledge of cGMP requirements, processes, procedures, and systems. Working knowledge of computer software applications such as word processing and spreadsheets. Must be very detail- oriented. Must be able to make independent decisions when issues arise, and upper management is not available. Must be able to multi-task and prioritize effectively.

Responsibilities

The Director of Quality leads all quality assurance/control for the repackaging/relabeling department, ensuring FDA 211 cGMP compliance. This includes managing quality management systems, audits, investigations, and overseeing product release to guarantee safety and efficacy.