Quality Technical Director - Greenville, United States - PAI Holdings LLC

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.