Quality Assurance Manager

Position Summary:

The Quality Assurance (QA) Manager will provide leadership and oversight of the manufacturing site Quality Systems to ensure compliance with FDA, ICH, and other applicable regulatory requirements. This role is responsible for managing QA Operations, Manufacturing Quality Assurance (MQA), Receiving Inspection, batch record release, and scientific data review. The QA Manager leads product and system investigations, applies structured root cause analysis (RCA), and leverages Six Sigma tools to implement effective CAPAs and drive continuous improvement. This position ensures facility audit readiness for regulatory inspections, and promotes a culture of quality, compliance, and operational excellence across the organization.

Key Responsibilities

Quality System Management:

* Ensure compliance across all quality systems.
* Maintain systems and ensure timely review, approval, and management of SOPs, investigations, CAPAs, scientific data review, and risk assessments.
* Maintain robust document control, department training, and record-keeping.
* Support validation and qualification activities (process, equipment, cleaning, computerized systems, and analytical methods).
* Perform and oversee comprehensive review of executed batch records for completeness, accuracy, and compliance prior to release.
* Review supporting scientific and analytical data (stability, QC testing, environmental monitoring, method validation/verification data) to confirm compliance with specifications, SOPs, and regulatory requirements.
* Ensure data compliance with ALCOA+ principles.

Product and System Investigations:

* Manage product and system investigations (e.g., deviations, OOS results, OOT, customer complaint support, and nonconformances).
* Ensure robust root cause analysis (RCA) is applied using appropriate methodologies.
* Apply Six Sigma tools (DMAIC, process mapping, statistical analysis, FMEA) to improve investigation quality and prevent recurrence.
* Ensure CAPAs are effective, timely, and verifiable, with measurable improvements in quality performance.

Manufacturing Quality Assurance (MQA) Oversight:

* Partner with manufacturing to ensure real-time deviation capture and rapid, effective resolution.
* Provide Quality Assurance management presence and MQA support on manufacturing and packaging areas to ensure real-time compliance oversight.

Receiving Inspection and Material Quality:

* Manage Receiving Inspection to ensure incoming materials, components, and raw materials meet specifications.
* Verify supplier documentation (Certificates of Analysis, Certificates of Compliance, certifications) and ensure compliance with data integrity requirements.
* Oversee risk-based sampling, inspection, and testing of raw materials and components.
* Partner with Supply Chain and Supplier Quality to address supplier issues.

Compliance and Audits:

* Prepare, assist, and lead regulatory inspections (FDA) and third-party audits.
* Manage internal audit program and ensure timely resolution of findings.
* Provide compliance guidance to Operations, QC, Supply Chain, and R&D.
* Ensure ALCOA+ principles are embedded into all systems and software.
* Maintain full compliance with 21 CFR Parts 11, 201, and 211, as well as other applicable international regulations and guidelines.

Product Quality Oversight:

* Review and approve production, testing, and validation records prior to product release.
* Oversee complaint investigations (plant level), including adverse event assessments, ensuring regulatory compliance.
* Partner with QC and Operations to analyze trends and implement improvements based on trend data.
* Drive data-driven decision-making to improve batch release accuracy and timeliness.

Leadership and Training:

* Lead, coach, and develop QA staff across MQA, Receiving Inspection, and QA Operations.
* Provide training on cGMP, cGxP, compliance, SOPs, root cause analysis, Six Sigma tools, and data integrity (ALCOA+).
* Foster a culture of accountability, transparency, and continuous compliance.

Continuous Improvement and Risk Management:

* Identify, evaluate, and implement initiatives to improve compliance, efficiency, and operational excellence.
* Lead risk assessments (FMEAs) and develop mitigation strategies.

Qualifications:

Education and Experience:

* Bachelor's degree in Science, Engineering or related field required.
* Minimum 7-10 years pharmaceutical QA experience, including 4 years in a managerial/leadership role.
* Direct experience in product and system investigations, root cause analysis, and Six Sigma methodologies required.
* Experience with FDA inspections and third-party audits is required.
* Oversight of MQA, Receiving Inspection, batch record review, and scientific data review required.

Knowledge and Skills:

* Comprehensive knowledge of cGMP (21 CFR Parts 11, 210 and 211), ICH Q7-Q10, USP, ISO 9001, and MoCRA.
* Strong working knowledge of root cause analysis tools and Six Sigma methodologies.
* Expertise in QMS, deviation/CAPA, document management, and ERP systems.
* Strong understanding of ALCOA+ data integrity principles.
* Proven leadership skills with the ability to inspire, develop, and guide highperforming QA teams.
* Excellent organizational, critical thinking, and problemsolving skills.
* Strong communication and interpersonal skills for effective crossfunctional collaboration.

Key Competencies:

* Regulatory Expertise: Comprehensive knowledge of FDA and global quality requirements.
* Investigative Rigor: Skilled in product/system investigations using RCA and Six Sigma tools.
* Data Integrity Stewardship: Champion ALCOA+ compliance across all functions.
* Leadership: Inspires, develops, and manages the Quality team.
* Collaboration: Builds effective partnerships with Manufacturing, QC, R&D, Engineering, and Supply Chain.
* Accountability: Ensures consistent, accurate, and compliant decisionmaking.

Working Conditions:

* Primarily officebased with frequent interaction in operations, warehouse, and laboratory areas.
* Must be available to support regulatory inspections, which may require extended or offshift hours.
* May require domestic or international travel to support audits, supplier visits, or training