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Quality Technical Director

4 months ago

Greenville, United States PAI Holdings LLC Full time

Job Description

Job Description

Quality Technical Director

JOB SUMMARY:

The Quality Technical Director will report directly to the Sr. Director of Quality. This is a unique position to the organization, as it will provide oversight and management of the PAI Pharma Complaint, Deviation, CAPA, and Document Management processes.

This role will:

Directly manage 10 employees in the areas of Deviations, CAPAs, Document Control, Complaints, and Quality IT Systems Management. Evaluate initial quality reviews of deviations for assessment of 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 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 that are aligned with business and quality initiatives and in compliance with all regulatory requirements. Develop, implement, and maintain procedures and work instructions to support the administration of the quality system. Recommend and implement quality system process improvements driven by new regulations, industry standards, new technologies, and internal business needs. 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.

Education and Experience Requirements: Due to the independent nature of decision making, the below requirements for experience and education are necessary to be effective in this role: Bachelor’s degree in Chemistry or a related medical, science, or regulatory discipline is required. 12+ years of total experience in the pharmaceutical manufacturing industry in a quality role. 10+ years of quality system experience is required, with 7+ years of experience leading Quality processes, managing Quality sub-systems at a functional level, and handling cGMP quality system

regulations/investigations. Must have extensive experience working with and collaborating with cross-functional teams. Demonstrated strong proficiency with Agile and Microsoft Office systems (Excel, PowerPoint, Word, and Project). 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.

Required Skills and Abilities: Excellent verbal and written communication skills; strong questioning and listening skills, and the ability to look beyond obvious answers to understand the impact on other areas. Strong influencing and negotiation skills. Significant attention to detail. Ability to drive timelines across multiple functional groups and leaders, with minimal management

oversight/direction. Ability to make effective presentations to all levels of the organization. Ability to work in both a collaborative team environment as well as perform independent work. Proven ability to prioritize and manage multiple projects and meet deadlines.

PAI is an Equal Opportunity Employer. PAI uses E-Verify. EEO Employer / Veteran / Disabled.

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