What are the responsibilities and job description for the QA Manager - 172434 position at Piper Companies?
Piper Companies is looking for a Quality Assurance Manager to join a biotechnology company located in Elkridge, MD.
Responsibilities of the Quality Assurance Manager include:
Keywords: Quality Assurance Manager, QA Manager, GMP, cGMP, FDA, EMA, ICH, Regulatory Compliance, Regulatory Inspections, FDA Inspections, Audit Readiness, Quality Systems, Quality Management System (QMS), CAPA, Corrective and Preventive Actions, Deviations, Non-Conformance Investigations, Root Cause Analysis, Change Control, Quality Risk Management, Risk Assessments, Risk Mitigation, Product Complaints, Supplier Complaints, Adverse Events, Out of Specification (OOS), Out of Trend (OOT), Quality Events, Batch Record Review, Batch Release, Material Release, Raw Material Release, Manufacturing Oversight, QA Floor Support, Quality Oversight, Process Improvement, Continuous Improvement, Technical Review, Document Control, Electronic Document Management System (eDMS), MasterControl, Controlled Documents, SOP Management, Training Management, Records Management, Data Integrity, ALCOA , Good Documentation Practices (GDP), Validation Documentation, Qualification Documentation, Supplier Quality, Vendor Management, Internal Audits, Supplier Audits, Quality Metrics, KPI Development, Inspection Readiness, Regulatory Responses, Quality Compliance, Pharmaceutical Manufacturing, Biotechnology Manufacturing, Aseptic Processing, Cleanroom Operations, ISO 5, Investigation Management, Cross-Functional Leadership, Quality Operations, Quality Review, Technical Writing, Process Controls, Quality Governance, Pharmaceutical Quality Systems (PQS), cGMP Documentation, Health Authority Regulations, Manufacturing Support, Compliance Management, Quality Assurance Leadership.
Responsibilities of the Quality Assurance Manager include:
- Manage daily operations and performance of the Quality Assurance and Document Control staff.
- Review, approve, and maintain quality documentation including deviations, CAPAs, change controls, investigations, procedures, protocols, and qualification records.
- Lead regulatory inspections, internal audits, supplier audits, and support audit readiness activities.
- Oversee document control processes, eDMS administration, training workflows, employee training records, and controlled document management.
- Manage product complaints, supplier complaints, adverse events, and risk assessments through investigation and closure.
- Perform QA oversight of manufacturing activities including room release, batch record review, critical process observation, and issue resolution.
- Ensure compliance with cGMP requirements, FDA regulations, company SOPs, and quality systems.
- Develop quality metrics/KPIs, support process improvements, and coordinate cross-functional quality initiatives.
- Review Quality Control testing data and support raw material and consumable release activities.
- Provide quality and eDMS training to internal and external users.
- Bachelor’s degree in a scientific discipline or equivalent experience; Associate degree considered with additional relevant experience.
- 8 years of experience in a GMP-regulated environment within the pharmaceutical, biotechnology, or related industry.
- Experience working in an FDA-regulated environment with direct involvement in regulatory inspections.
- Strong knowledge of cGMP requirements and US/EU regulatory standards.
- Previous leadership or supervisory experience managing QA personnel preferred.
- Experience with document control systems, preferably MasterControl.
- Strong technical writing, organization, communication, and problem-solving skills.
- Rate Range: $115,000 - $135,000 annually
- Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
Keywords: Quality Assurance Manager, QA Manager, GMP, cGMP, FDA, EMA, ICH, Regulatory Compliance, Regulatory Inspections, FDA Inspections, Audit Readiness, Quality Systems, Quality Management System (QMS), CAPA, Corrective and Preventive Actions, Deviations, Non-Conformance Investigations, Root Cause Analysis, Change Control, Quality Risk Management, Risk Assessments, Risk Mitigation, Product Complaints, Supplier Complaints, Adverse Events, Out of Specification (OOS), Out of Trend (OOT), Quality Events, Batch Record Review, Batch Release, Material Release, Raw Material Release, Manufacturing Oversight, QA Floor Support, Quality Oversight, Process Improvement, Continuous Improvement, Technical Review, Document Control, Electronic Document Management System (eDMS), MasterControl, Controlled Documents, SOP Management, Training Management, Records Management, Data Integrity, ALCOA , Good Documentation Practices (GDP), Validation Documentation, Qualification Documentation, Supplier Quality, Vendor Management, Internal Audits, Supplier Audits, Quality Metrics, KPI Development, Inspection Readiness, Regulatory Responses, Quality Compliance, Pharmaceutical Manufacturing, Biotechnology Manufacturing, Aseptic Processing, Cleanroom Operations, ISO 5, Investigation Management, Cross-Functional Leadership, Quality Operations, Quality Review, Technical Writing, Process Controls, Quality Governance, Pharmaceutical Quality Systems (PQS), cGMP Documentation, Health Authority Regulations, Manufacturing Support, Compliance Management, Quality Assurance Leadership.
Salary : $115,000 - $135,000