Quality Technical Director

4 weeks ago

Greenville, United States PAI Holdings LLC Full time
Job DescriptionJob 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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