Germer International - Pharmaceutical Recruiting
Director of Quality
Germer International - Pharmaceutical Recruiting, Charlotte, North Carolina, United States, 28245
Overview
Our client, a global leader in the development and manufacturing of injectables, is looking for a Quality professional who can manage audits and quality systems at their manufacturing site. Director of Quality Assurance – Site Investigations & Quality Systems Position Summary
This position is responsible for overall adequacy of all non-conformances investigations logged at the site in respect to local and global procedures as applicable. Ensuring that non-conformances are thoroughly investigated, root causes substantiated, and adequate and effective CAPAs are implemented. The ideal candidate will identify atypical product quality trends and escalate in a timely manner to site and corporate levels. This role will implement corporate investigation and harmonization strategies and represent the site. Experience handling US FDA inspections and responding to observations; under the direction of the Senior Director of Quality, the position is responsible for implementing and managing systems related to GxP compliance, including but not limited to: Document Control, Electronic Quality Management Systems (Investigation, Change Control, CAPA) and Annual Product Review (APR). Responsibilities
Participate in preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation, and management within approved budgets while building the site's best-in-class quality processes and systems. Maintain quality system controls to ensure no critical and major market complaints. Handle QMS documents such as Quality Event/deviation investigations, Change Control, APR, etc. Review QMS documents such as OOS, OOT, Incidents/deviations, CAPA. Perform Root Cause Analysis of events (OOS, deviations, or failures) using tools such as Fishbone diagrams, 5 WHY, IS–IS NOT, Process Mapping/Flow Charts, Interviews and brainstorming. Review the adequacy and effectiveness of CAPA against root cause investigations. Respond to internal and external audit observations related to investigations; serve as site representative for Quality Systems during regulatory inspections and corporate audits. Identify and notify atypical product quality trends; lead and develop quality systems personnel and drive a quality culture at the site. Establish, revise, and continuously improve procedures for all Quality Systems and coordinate the implementation of global policies and procedures at the site. Stakeholders
Coordinate with Production/R&D/QA/QC/Validation for various activities Lead and coordinate APR activities with stakeholders Periodically review SOPs of QA/Production/Warehouse/QC/Validation/IT, etc. Operate in compliance with cGMP, 21 CFR, USP, EP and ICH regulatory requirements Education
Bachelor of Pharmacy or relevant science degree Knowledge and Skills
15-25 years in the pharmaceutical industry with experience in investigations, sterile manufacturing quality assurance, validation and qualifications, quality systems and compliance, auditing, Good Distribution Practices, and related areas. Seniority
Director Employment type
Full-time Job function
Quality Assurance, Manufacturing, and Management Industries
Pharmaceutical Manufacturing Note: This refined description removes extraneous boilerplate and duplicate fields while preserving the core responsibilities and qualifications of the role.
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Our client, a global leader in the development and manufacturing of injectables, is looking for a Quality professional who can manage audits and quality systems at their manufacturing site. Director of Quality Assurance – Site Investigations & Quality Systems Position Summary
This position is responsible for overall adequacy of all non-conformances investigations logged at the site in respect to local and global procedures as applicable. Ensuring that non-conformances are thoroughly investigated, root causes substantiated, and adequate and effective CAPAs are implemented. The ideal candidate will identify atypical product quality trends and escalate in a timely manner to site and corporate levels. This role will implement corporate investigation and harmonization strategies and represent the site. Experience handling US FDA inspections and responding to observations; under the direction of the Senior Director of Quality, the position is responsible for implementing and managing systems related to GxP compliance, including but not limited to: Document Control, Electronic Quality Management Systems (Investigation, Change Control, CAPA) and Annual Product Review (APR). Responsibilities
Participate in preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation, and management within approved budgets while building the site's best-in-class quality processes and systems. Maintain quality system controls to ensure no critical and major market complaints. Handle QMS documents such as Quality Event/deviation investigations, Change Control, APR, etc. Review QMS documents such as OOS, OOT, Incidents/deviations, CAPA. Perform Root Cause Analysis of events (OOS, deviations, or failures) using tools such as Fishbone diagrams, 5 WHY, IS–IS NOT, Process Mapping/Flow Charts, Interviews and brainstorming. Review the adequacy and effectiveness of CAPA against root cause investigations. Respond to internal and external audit observations related to investigations; serve as site representative for Quality Systems during regulatory inspections and corporate audits. Identify and notify atypical product quality trends; lead and develop quality systems personnel and drive a quality culture at the site. Establish, revise, and continuously improve procedures for all Quality Systems and coordinate the implementation of global policies and procedures at the site. Stakeholders
Coordinate with Production/R&D/QA/QC/Validation for various activities Lead and coordinate APR activities with stakeholders Periodically review SOPs of QA/Production/Warehouse/QC/Validation/IT, etc. Operate in compliance with cGMP, 21 CFR, USP, EP and ICH regulatory requirements Education
Bachelor of Pharmacy or relevant science degree Knowledge and Skills
15-25 years in the pharmaceutical industry with experience in investigations, sterile manufacturing quality assurance, validation and qualifications, quality systems and compliance, auditing, Good Distribution Practices, and related areas. Seniority
Director Employment type
Full-time Job function
Quality Assurance, Manufacturing, and Management Industries
Pharmaceutical Manufacturing Note: This refined description removes extraneous boilerplate and duplicate fields while preserving the core responsibilities and qualifications of the role.
#J-18808-Ljbffr