Pharmaceutical Quality Director - Greenville, United States - HTI

Description

HTI has an immediate opening for an experienced Pharmaceutical Quality Technical Director for a large pharma manufacturer in Greenville, SC. This is a full-time, salaried, onsite position. Relocation assistance is available. Salary depends on experience and education, and the range is approximately $125,000 – $150,000 / year.

Job Summary:

This position reports directly to the Sr. Director of Quality. This is a unique position to the organization, as it will provide oversight and management of the Complaint, Deviation, CAPA/investigations, and Document Management teams and processes.

Requirements:

• Must have a Bachelor's degree in Chemistry or a related medical, science, or regulatory discipline.
• Must have 10+ years of experience in the pharmaceutical manufacturing industry in a quality role.
• Must have 7+ years of experience in a Quality Management role, leading Quality processes, managing Quality sub-systems at a functional level, and handling cGMP Quality system regulations/investigations.
• Must have strong leadership and people management skills.
• CFR 210 and CFR 211 experience required.
• Excellent verbal and written communication skills.
• Demonstrated proficiency with Agile and Microsoft Office software; TrackWise preferred.
• ASQ Certifications for Auditing and/or Quality Management are preferred.
• Regulatory Affairs experience is preferred.
• Experience with Six Sigma Process Excellence tools, training and/or certification is a plus.
• Experience with documentation and technical writing skills, in a regulated compliance environment, is preferred.
• Must be authorized to work in the United States.

Job duties:

• Directly manage 10 employees in the areas of Deviations, CAPAs, Document Control, Complaints, and QMS IT Systems.
• Evaluate initial Quality reviews of Deviations for assessment for field alerts, recalls, and immediate action for all investigations.
• Manage timing of investigations between Deviation group and Operations for timely closure; ensure extension requests are performed and adequate to cause.
• Contribute to the investigation process to determine root cause, directing investigations with face-to-face meetings and on the floor communication.
• Coordinate immediate CAPAs (Corrective and Preventive Actions) with process owners.
• Drive task-oriented CAPA review and closures each month.
• Implement reduction of repetitive deviations.
• Manage Document changes to support CAPA closures.
• Manage Customer Complaint systems by reviewing Safety Call notifications.
• Determine Product Quality Complaints and ADE based on notifications.
• Ensure timely investigations and closure of complaints in TrackWise QMS System.
• Manage Change Control system, both manually and within TrackWise.
• Determine applicable routing of Change Controls to the appropriate system owners.
• Coordinate with all impacted stakeholders to ensure that changes are agreed upon and effectively implemented.
• Manage Change Control closures and/or extensions on time.
• Quality assessments of Laboratory Investigations for OOS/OOT events; ensure FDA compliance testing is followed.
• Support obtaining data for Annual Product Reviews for all departments.
• Manage Quality IT system employees/functions that support TrackWise, eInfotree, Compliance Wire, and Blue Mountain systems.
• Drive standardized implementation of the assigned Quality processes across the site.
• Define and execute mission, vision, and strategy for both short and long-term program maturity in performance and compliance of quality system processes.
• Serve as primary point of contact and SME (subject matter expert) for Quality in regards to the development of or migration to any new Quality IT system platforms.
• Manage the Review Boards for CAPAs and Complaint processes, and coordinate with all functional leaders to ensure accuracy and completeness of all data and metrics.
• Ensure adherence to policies and procedures and identify/implement tools and training to continuously improve the Quality system.
• Develop and implement Complaint and CAPA/Deviation procedures, work instructions and training to maintain compliance to standards and regulations; continuously identify and implement process improvements.
• Prepare for and participate in all Regulatory and Customer audits.

Quality Management System

• Participate directly in establishing strategic direction for Quality system activities
• Develop, implement, and maintain procedures and work instructions to support the administration of the Quality system.
• Recommend and implement Quality system process improvements
• Maintain current knowledge of, and compliance with, the full range of related Quality systems, technology, regulatory requirements, and related policies and procedures.
• Ensure adequate training is conducted and competency is maintained among key process stakeholders.
• Participate in external and internal Regulatory Compliance inspections.
• Participate in Management Review meetings as required.

EEO Employer / Veteran / Disabled.

Keywords: Pharma, Pharmaceutical Quality, Pharmaceutical manufacturing, Quality Director, Technical Director, Quality Manager, Quality Management, QMS, QMS Systems, CAPA, Investigations, Deviations, Document Control, Chemistry, TrackWise, cGMP, FDA, CFR 210, CFR 211