Quality Assurance Manager

QntmLogic, LLC.; Indiana (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

QntmLogic, LLC. seeks a Quality Manager to oversee GxP/QA operations for pharmaceutical/life-science warehousing and distribution at the Whiteland, Indiana facility.

You will lead the Quality Assurance Unit, drive quality strategy, manage audits, CAPAs, investigations, and partner with Operations to meet regulatory and client requirements.

Responsibilities include developing and maintaining quality policies, KPIs, and training warehouse personnel on GxP, GDP, and quality requirements.

Qualifications

• 7–10 years of pharmaceutical/life-sciences quality operations experience.
• Bachelor’s degree in Biochemistry, Chemistry, Biology, or STEM preferred.

Responsibilities

• Develop and maintain quality strategy, policies, SOPs/work instructions, processes, and quality culture.
• Interpret and apply GxP regulations to operational and compliance issues.
• Manage internal/external audits, regulatory inspections, assessments, CAPAs, investigations, and non-compliance issues.
• Own quality metrics/KPIs and provide quarterly quality performance reporting to leadership.
• Act as the primary quality contact for pharmaceutical clients/customers, including QBRs and quality requests.
• Monitor CQA and CPP and recommend improvements.
• Lead risk management, quality projects, and GxP-related change initiatives.
• Partner with Operations to manage resources, priorities, schedules, and quality objectives.
• Develop and train warehouse personnel on GxP, GDP, compliance, and quality requirements.
• Manage/mentor Quality personnel and lead cross-functional/matrix teams.
• Support regulatory agency interactions and ensure client and regulatory requirements are met.
• Identify regulatory/business changes and assess their impact on warehouse quality.

Skills

GxP/GMP/GDP

Pharma distribution

QA/Quality management

Audits & inspections

CAPA & investigations

SOPs & quality systems

Training & LMS

Quality metrics

Leadership

Education

Bachelor’s in STEM

Job description

Quality Manager overseeing GxP/QA operations for pharmaceutical/life-science warehousing and distribution at the Whiteland, Indiana facility.

About the Role

Core responsibilities include leading the Quality Assurance/Quality Unit and serving as the primary quality authority for warehouse/distribution operations.

Responsibilities

• Develop and maintain quality strategy, policies, SOPs/work instructions, processes, and quality culture.
• Interpret and apply GxP regulations to operational and compliance issues.
• Manage internal/external audits, regulatory inspections, assessments, CAPAs, investigations, and non-compliance issues.
• Own quality metrics/KPIs and provide quarterly quality performance reporting to leadership.
• Act as the primary quality contact for pharmaceutical clients/customers, including QBRs and quality requests.
• Monitor CQA (Critical Quality Attributes) and CPP (Critical Process Parameters) and recommend improvements.
• Lead risk management, quality projects, and GxP-related change initiatives.
• Partner with Operations to manage resources, priorities, schedules, and quality objectives.
• Develop and train warehouse personnel on GxP, GDP, compliance, and quality requirements.
• Manage/mentor Quality personnel and lead cross-functional/matrix teams.
• Support regulatory agency interactions and ensure client and regulatory requirements are met.
• Identify regulatory/business changes and assess their impact on warehouse quality.

Qualifications

• 7–10 years of pharmaceutical/life-sciences quality operations experience.
• Bachelor's degree in Biochemistry, Chemistry, Biology, or STEM preferred.

Required Skills

• Strong experience with:
• GxP / GMP / GDP
• Pharmaceutical distribution / 3PL / warehouse operations
• Quality Assurance / Quality Management
• Audits and regulatory inspections
• CAPA, deviations, investigations
• SOPs / quality systems
• Training / LMS
• Quality metrics and reporting
• Leadership experience managing QA personnel or cross-functional teams.