Job Description

Description:

The Challenge Printing Company is dedicated exclusively to producing pharmaceutical printed components. Founded in New York City in 1911, Challenge moved to northern New Jersey in the mid-1960s. A second manufacturing facility was opened near Sanford, North Carolina, in 1993. More recently, the corporate headquarters moved to a new, state-of-the-art facility in Clifton, New Jersey, in 2004. A new manufacturing site was opened in Sanford in September of 2007. The company remains privately held by its founding family.

By focusing on the unique needs of the pharmaceutical industry, Challenge can compete successfully within its niche against much larger printing firms. Timely investment in new plants and equipment creates an environment where significant growth is possible. To realize corporate expansion plans, exceptional performance is needed from all employees. As guidance to help achieve these goals, the following seeks to outline the minimum responsibilities of the Director of Quality. Requirements:

• Lead implementation of corporate quality procedures at the assigned manufacturing site.
• Partner with directors, managers, and ownership and contribute to continuous corporate improvement efforts.
• Ensure that customer requirements are met.
• Help refine processes and procedures to build quality into the manufacturing process.
• Assume site responsibility for managing the following quality metrics:

Deviation notifications

Vendor performance, including Corrective Action/Preventive Action requests; all regular audits

Non-conformance with customer quality expectations (External Complaints), including written responses and CAPAs

Non-conformance with Challenge\'s quality expectations (Internal Complaints), including written responses

• Site responsibility for recruitment and development of a talented Quality Assurance staff.
• Counsel senior management on those aspects of daily operations that may impact the site\'s achievements of appropriate quality standards.
• Ensure that the site is prepared to pass a customer quality audit.
• Site responsibility for representing Challenge during customer quality audits.
• Working in coordination with other sites, regularly performing internal quality audits of all Challenge departments, and formally reporting findings to corporate management.
• In the absence of higher management review, exercise appropriate critical decision-making authority in handling quality issues.
• Interact functionally with all other departments.
• Hold Quality Assurance department employees accountable for adherence to safety, Standard Operating Procedures, and cGMP requirements.
• Assume direct responsibility for site Supervisor of Quality Assurance and indirect responsibility for site Quality Assurance Technicians.
• Coordinate site validation efforts.
• At all times, exemplify the highest business and personal integrity level.

PM22

PI224584419

The Challenge Printing Company Inc