Staqpharma
Quality Assurance Manager
Staqpharma, Columbus, Ohio, United States, 43224
As a hospital-backed and directed pharmaceutical outsourcing supplier, STAQ Pharma is positioned to strengthen the supply chain for drug shortages, understand healthcare provider needs, and ensure patients receive the safest medication.Our commitment to addressing drug shortages and providing critical medications is fostered by the four fundamental values embodied in our name:
Safety, Transparency, Availability,
and
Quality.
Every aspect of our operations, oversight and execution occurs with these values at our core.We are seeking an experienced
Quality Assurance (QA) Manager
with a proven track record in the pharmaceutical industry, particularly in a 503B outsourcing facility. This role is for individuals who have led small teams, driven the implementation and continuous improvement of Quality Management Systems (QMS), and have hands-on experience in deviation investigations, CAPA management, and batch review. The ideal candidate will be deeply familiar with FDA, DEA, and state audits, serving as a Subject Matter Expert (SME) during regulatory inspections. As the
QA Manager , you will play a pivotal role in ensuring that the facility maintains compliance with Current Good Manufacturing Practices (CGMP) and quality standards, while driving efficiency and continuous improvement in our processes. This role demands a hands-on leader who thrives in dynamic environments and enjoys mentoring teams while collaborating with cross-functional departments.Responsibilities:
Lead and oversee the implementation and maintenance of the Quality Management System (QMS), ensuring CGMP compliance at all times.Provide leadership and guidance in the resolution of quality issues, including deviations and CAPAs, ensuring timely completion and effective resolution.Act as a Subject Matter Expert (SME) during FDA, DEA, and state audits, as well as internal and external customer audits.Manage the batch review and release process, ensuring all products meet CGMP requirements and all unexplained discrepancies are investigated and resolved.Author, review, and approve Standard Operating Procedures (SOPs) and Work Instructions, ensuring compliance with quality standards and regulatory requirements.Drive large-scale projects aimed at process improvement, risk mitigation, and continuous improvement initiatives within the Quality department.Lead deviation investigations, identify root causes, and oversee the development of effective CAPA plans, ensuring timely completion and tracking.Oversee the supplier management program, conducting supplier audits, handling complaints, and managing corrective actions related to supplier performance.Develop, monitor, and report on key Quality department metrics and Key Performance Indicators (KPIs) to ensure continuous improvement and compliance.Lead and mentor a team of Quality Assurance professionals, fostering a culture of quality and compliance within the organization.Maintain and manage internal audit schedules, ensuring timely execution of audits and subsequent corrective actions.Collaborate with cross-functional teams to manage change controls and assess risks to validated CGMP systems, processes, and equipment.Qualifications:
Advanced skills with Microsoft Office (Word, Excel, etc.).5 to 7 years of experience in a CGMP-regulated environment, with at least 3 years in a leadership or decision-making role.Bachelor’s degree in a related field (B.S. or B.A. required).Extensive experience with FDA, DEA, and state regulatory inspections, serving as a key member of the audit team.Strong knowledge of deviation investigations, CAPA processes, QMS rollouts, and quality systems.Exceptional problem-solving and root cause analysis skills, with experience driving corrective actions and continuous improvement initiatives.Excellent communication and leadership skills, with the ability to guide and mentor teams.Proficiency in technical writing, particularly with SOPs, deviation investigations, and audit responses.Familiarity with lean manufacturing principles and 5S methodologies is preferred.Apply Online#J-18808-Ljbffr
Safety, Transparency, Availability,
and
Quality.
Every aspect of our operations, oversight and execution occurs with these values at our core.We are seeking an experienced
Quality Assurance (QA) Manager
with a proven track record in the pharmaceutical industry, particularly in a 503B outsourcing facility. This role is for individuals who have led small teams, driven the implementation and continuous improvement of Quality Management Systems (QMS), and have hands-on experience in deviation investigations, CAPA management, and batch review. The ideal candidate will be deeply familiar with FDA, DEA, and state audits, serving as a Subject Matter Expert (SME) during regulatory inspections. As the
QA Manager , you will play a pivotal role in ensuring that the facility maintains compliance with Current Good Manufacturing Practices (CGMP) and quality standards, while driving efficiency and continuous improvement in our processes. This role demands a hands-on leader who thrives in dynamic environments and enjoys mentoring teams while collaborating with cross-functional departments.Responsibilities:
Lead and oversee the implementation and maintenance of the Quality Management System (QMS), ensuring CGMP compliance at all times.Provide leadership and guidance in the resolution of quality issues, including deviations and CAPAs, ensuring timely completion and effective resolution.Act as a Subject Matter Expert (SME) during FDA, DEA, and state audits, as well as internal and external customer audits.Manage the batch review and release process, ensuring all products meet CGMP requirements and all unexplained discrepancies are investigated and resolved.Author, review, and approve Standard Operating Procedures (SOPs) and Work Instructions, ensuring compliance with quality standards and regulatory requirements.Drive large-scale projects aimed at process improvement, risk mitigation, and continuous improvement initiatives within the Quality department.Lead deviation investigations, identify root causes, and oversee the development of effective CAPA plans, ensuring timely completion and tracking.Oversee the supplier management program, conducting supplier audits, handling complaints, and managing corrective actions related to supplier performance.Develop, monitor, and report on key Quality department metrics and Key Performance Indicators (KPIs) to ensure continuous improvement and compliance.Lead and mentor a team of Quality Assurance professionals, fostering a culture of quality and compliance within the organization.Maintain and manage internal audit schedules, ensuring timely execution of audits and subsequent corrective actions.Collaborate with cross-functional teams to manage change controls and assess risks to validated CGMP systems, processes, and equipment.Qualifications:
Advanced skills with Microsoft Office (Word, Excel, etc.).5 to 7 years of experience in a CGMP-regulated environment, with at least 3 years in a leadership or decision-making role.Bachelor’s degree in a related field (B.S. or B.A. required).Extensive experience with FDA, DEA, and state regulatory inspections, serving as a key member of the audit team.Strong knowledge of deviation investigations, CAPA processes, QMS rollouts, and quality systems.Exceptional problem-solving and root cause analysis skills, with experience driving corrective actions and continuous improvement initiatives.Excellent communication and leadership skills, with the ability to guide and mentor teams.Proficiency in technical writing, particularly with SOPs, deviation investigations, and audit responses.Familiarity with lean manufacturing principles and 5S methodologies is preferred.Apply Online#J-18808-Ljbffr