What Does A Head of QA Do?

WHAT DOES A HEAD OF QA DO?

Published: May 12, 2025 - The Head of QA oversees compliance operations including risk management, internal audits, inspection readiness, and continuous improvement across all GxP functions. This role leads quality initiatives, enhances data integrity controls, and ensures regulatory compliance through policy development and cross-functional collaboration. The head manages performance metrics, quality reviews, and improvement efforts to maintain a consistent state of operational excellence.

A Review of Professional Skills and Functions for Head of QA

1. Head of QA Duties

Quality System Management: Improve and maintain the existing Quality management system
GMP Compliance: Comply with GMP and other related laws and regulations
Team Development: Foster skilled human resources and enhance the organization of the GMP and QA department
QA Strategy Proposal: Propose a quality assurance strategy in line with the QA strategy
Product Quality Assurance: Assure the quality of products in line with the global product standard
QMS Improvement: Maintain and improve the quality management system
Product Release Approval: Approve of products to release
Quality Agreement Negotiation: Negotiate a quality agreement with the partner/contractor
Cross-Functional Collaboration: Collaborate with related functions in Japan and HQ, other production sites for Quality improvement
Quality Control Management: Manage Deviation, Change control, Use’s complaints, Document control, Validation and so forth correctly
Audit Readiness: Respond successfully to the Audit and Inspection by Authority and Partners
QA Budget Management: Manage the budget for the QA department
QA Team Cooperation: Cooperate with the quality assurance manager and GQP

2. Head of QA Details

QA Function Setup: Setting up a QA function
Quality System Implementation: Implement and maintain a Quality System that addresses the critical role quality and regulatory compliance play in Xbrane Biopharma’s business
GxP Compliance Collaboration: Collaborate with all of Xbrane’s departments to identify relevant quality standards and to ensure GxP compliance is met and maintained
Quality Culture Development: Share information, organise training and evolve the quality culture within Xbrane
GxP Knowledge Update: Keep up to date in the field of Quality Assurance and GxP
Stakeholder Relationship: Establish strong relationships with internal and external partners
Quality Agreement Oversight: Establish and maintain Quality Agreements with external partners in e.g., Manufacturing, Supply Chain, Clinical Affairs and ensure the commitments are honoured
Document Review: Review documentation by external partners to ensure relevant quality standards and agreements are met
Audit Management: Create and maintain an audit plan and lead internal and external audits
Inspection Support: Support inspections (e.g., FDA, EMA) and the closing out of associated findings
Document Approval: Review and approve quality-related documentation such as Change Control, Deviation Reports and CAPAs

3. Head of QA Responsibilities

Local QMS Management: Develop and maintain a local quality system to support the release of a commercial product
QA Activity Oversight: Conduct or supervision of quality assurance activities, including but not limited to, product release, self-inspection, training, handling of defects
Audit Execution: Conduct internal process audits and external supplier audits
Document Control: Control of documents related to quality assurance activities
SOP Ownership: Develop and own of local SOPs/Quality Management System related to Quality activities and review or approval of functional area procedures
Recall Communication: Communication with the necessary parties in the case of recall or discontinuation of manufacture or marketing
QA Department Setup: Support the establishment with a compliant assurance department for investigational and commercial products
Issue Reporting: Reporting of any quality-related issue to the Marketing Supervisor General (Sokatsu) and other management
Risk-Based System: Establish and maintain a risk-based and science-based Quality system
GMP Compliance: Ensure all GMP operations comply while maintaining an efficient workflow to facilitate operational excellence
Vendor Management: Manage Vendor Quality by executing a vendor quality management program including quality agreements and periodic assessment of vendor performance metrics
Regulatory Documentation: Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers
QA Support: Support the quality assurance function
Auditing Training: Provide support and training to other staff members to develop additional auditing resources
Cross-Department Collaboration: Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department

4. Head of QA Job Summary

Multi-Platform Testing: Work across VR, web and mobile platforms to create hands-on test builds
Project Reporting: Oversee the reporting of the QA projects to the wider team and stakeholders
QA Project Planning: Ensure QA projects are correctly planned, scheduled and budgeted
Team Leadership: Lead the QA team – hire, train and inspire reports to ensure an excellent QA
Task Management: Manage time efficiently between hands-on work and management tasks
QA Communication: Communicate effectively with external QA providers and internally across the team but focusing on the customer service team to ensure the best customer experience possible
QA/QE Strategy: Setting the strategy for both QE and QA to support the Product and Project sides of the business on a global basis
Principles Implementation: Owning the definition, description and implementation of QE and QA principles for global adoption in delivery assignments
Guild Leadership: Leading the QA/QE Guild as part of the Engineering organisation to help develop people in their chosen career path
Career Path Design: Creation of the career growth path, including cross-training between QE and QA
Certification Support: Supporting the work to maintain existing company-wide certifications (BSI 9001 and ISO 27001)
Strategic Staffing: Finding a balance between the tactical needs of the organisation for people in roles and the strategic needs to enhance and develop QA and QE experts
Assignment Support: Taking a more active role in the assignment of people to Delivery Assignments to help their career progression
Test Lab Ownership: Owner of the testing laboratories and test kits used in the delivery of the Project and Product

5. Head of QA Accountabilities

QA Strategy Deployment: Build a QA strategy and its deployment till the Improvement Project level
Scorecard Development: Develop a Monthly scorecard and a strong review mechanism
Statistical Analysis: Build a strong statistical problem-solving approach within the QA team
Quality Improvement: Continuously interact with Plant and Suppliers to work upon improving Product and Process Quality to improve Customer Satisfaction
Customer Feedback: Understand and Analyze Customer Escalations and provide feedback to Plant and Suppliers as well as R&D
Cost Analysis: Analyze the Cost of Poor Quality in terms of Rejections and Non-Moving Items and suggest corrective actions
Failure Analysis: Carry out Warranty Failure Analysis and provide feedback to R&D, Reliability and Plant Teams
DWM Deployment: Deploy Daily work management (DWM) and improve the Process capability of the processes
Quality Standards Setup: Set up Quality Standards and Systems in coordination with Plant, R&D and Reliability Teams
Vendor Quality Process: Set up process for assessing the quality of Bought Out Items through Local and International Vendors and methods for continuous improvements
Vendor Audits: Carry out SQP audits at all vendors
Vendor Coaching: Handhold to achieve and sustain expected scores
Vendor Scorecard: Develop a Vendor scorecard and review mechanism
Customer Visits: Carry out Branches and Customer visits to understand the Customer well
Escalation Feedback: Analyse Corporate Escalations and provide feedback to R&D, Reliability and plant Teams

6. Head of QA Functions

Quality Leadership: Being a first-class leader in developing quality as a way of life
Product Development Support: Working with the business to review the range and assist in new product development
QA/QC Oversight: Provide leadership and direction to ensure achievement of all site accountabilities for QA, QC and Stability
QA Training: Teach site QA and QC critical quality management skills, including decision-making, handling of quality exceptions, staff development, personnel and budget requirements planning, etc.
Quality Issue Assessment: Proactively assess quality issues at the site and ensure compliance with QA/QC regulatory requirements in manufacturing operations at the site and track quality metrics with the site manufacturing management and drive them down
Audit Readiness: Ensure sites are working along a consistent, internal audit-ready platform
QMS Establishment: Work within the Quality team and interface with key stakeholders to establish and maintain a phase-appropriate quality management system
Manufacturing Support: Provide guidance and support to manufacturing operations, including monitoring, sampling and stability programs
Batch Record Review: Review batch records for clinical products and in-process materials/components
QA Documentation: Develop and maintain QA processes, policies and documentation
Quality Event Management: Lead management of quality processes, including identification, resolution and documentation of quality events (deviations, CAPAs, etc) with cross-functional SMEs
Change Control Oversight: Provide QA oversight and support for change control, document control and training management
Process Compliance: Develop, implement and improve user and system processes to facilitate compliance
Supplier Quality: Support supplier qualification, audits, and implementation of computerized systems
Continuous Improvement: Provide guidance and work with others to identify opportunities for continuous improvement and to implement solutions utilizing quality system elements
GMP Integration: Ensure GMP compliance is built into the design and implementation of processes and systems
Performance Monitoring: Develop tracking metrics to monitor and improve performance

7. Head of QA Job Description

QA Team Leadership: Leadership of the QA Operations team
Batch Disposition Oversight: Responsible for batch disposition oversight of batch release processes
Quality Liaison: Main Quality contact for operational teams across the site
Quality Process Management: Management of key quality processes in partnership with operations, including batch disposition, deviation and CAPA management, on-time delivery, schedule adherence, product supply, risk assessments and change control
Procedure Development: Drive the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency
QA Program Design: Design and implementation of robust QA programs and practices
Quality Strategy Drafting: Draft the overall quality strategy to enhance growth and compliance readiness
QMS Development: Develop and maintain the company’s Quality Management System to fulfill international quality system requirements
QMS Implementation: Work closely with all staff to ensure that all aspects of the QMS are understood, implemented and maintained
SOP Review: Preparation and/or review of SOPs by international standards (i.e., GMP, GDP, ISO, PIC/S)
Document Control Setup: Set up and maintain controls and documentation procedures
QA Strategy Execution: Devise the QA strategy approach and execution in development projects
GxP Documentation: Preparing documentation to support GxP compliance

8. Head of QA Overview

QMS Oversight: Key market contact and responsible for all QMS activity and issues relating to the commercial business
QA Team Management: Managing the QA Manager and QA staff accordingly
Continuous Improvement Plan: Assess and proactively create and implement a continuous improvement plan for the adoption of the principles and requirements of a QMS into the commercial business, including identifying, understanding and sharing appropriate information
Quality Awareness: Heighten and promote quality and QMS awareness in the commercial business functions
Stakeholder Engagement: Engage and assist relevant stakeholders in understanding and generating appropriate systems, processes and policies within defined areas of the business, in compliance with QMS principles
Regulatory Intelligence: Develop a network to obtain local regulatory intelligence and provide the necessary analysis to understand and escalate issues
QMS Monitoring: Responsible for ensuring a sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status
SOP Compliance: Ensure that all SOPs are in place, updated and training has been conducted across the business
Training Tracking: Ensure a monitoring system is in place for tracking training compliance and a process for escalation of persistent non-compliance
QMS Promotion: Promote QMS management principles and seek continuous improvement of the processes
Policy Review: Review, conduct impact assessments and implement any updates to QMS policies
QMS Review Meetings: Manage QMS Management Review meetings according to local SOPs
QA Objectives: Identify, Implement and Manage QA Objectives and KPIs
Quality Planning: Establish and manage Annual Quality Plans

9. Head of QA Details and Accountabilities

QA Oversight: Ensure Quality assurance oversight of all Company activities
Customer Quality Focus: Ensure that customer service delivers to and aims to exceed customers' Quality Assurance expectations and metrics
Regulatory Compliance: Ensure that there is a quality and regulatory-compliant working environment and best practices are achieved
Team Development: Develop the Quality teams' effectiveness through leadership, coaching and performance management
Clinical Compliance: Ensure compliance with mandatory training and all regulatory requirements in the conduct of clinical trials
Inspection Readiness: Ensure that the company is Inspection Ready at all times and that Sponsor and Regulatory audits are undertaken professionally and result in positive outcomes for the company
Practice Standardization: Work with Oncology Site Network personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations, to ensure best practices are achieved
Team Leadership: Lead and develop the Quality Team across the organisation, ensuring team members have clear direction and accountabilities that meet business requirements
Quality Monitoring: Responsible for the implementation, update and maintenance of the Oncology Site Network quality control processes and management of a quality monitoring system
Global QA Alignment: Ensure standardisation of QA activities across the international company including the implementation of an annual global internal audit plan and Quality Control processes
Audit Support: Responsibility for providing support for external audit preparation and conduct at Sites and Central functions
Inspection Support: Manage and support sites with all aspects of regulatory and sponsor inspections to achieve positive outcomes
CAPA Management: Lead the Quality function to meet international standards through a robust CAPA and continuous improvement process
Framework Compliance: Ensure compliance with company quality framework, regulatory (GCP) legislation, guidelines and international standards
Client QA Review: Work with Business Development to provide quality reviews in advance of client meetings and attend client meetings with BD to represent the Quality Assurance view
Best Practice Knowledge: Ensure knowledge with regards to quality best practice requirements is kept up to date through reading and attending relevant forums

10. Head of QA Tasks

QA Compliance Oversight: Oversee the QA Compliance function responsible for Quality Risk Management, Internal Audits, Inspection Readiness, and Continuous Improvement
Strategic Quality Planning: Define strategic Quality initiatives and drive organizational change
Risk Mitigation: Work closely with department heads to identify and mitigate risk for the organization
Risk Assessment Management: Facilitate risk assessments and maintain the risk register
Inspection Readiness Leadership: Lead the inspection readiness efforts across SAGE, working closely with subject matter experts in GCP, GVP, GLP and GMP areas
Audit Coordination: Host regulatory inspections and audits and coordinate the drafting of responses
Internal Audit Management: Manage the internal audit program across the GXP functions
Data Integrity Oversight: As the Quality Data Integrity lead, evaluate and enhance data integrity controls
Process Improvement Collaboration: Partner with business stakeholders (internal and external) to improve business processes and systems controls to ensure data integrity throughout the lifecycle
Policy Enhancement: Enhance policies and procedures and ensure compliance with applicable regulations
Quality Review Management: Manage the Quality Management Review and provide quarterly updates to the Quality Steering Committee
KPI Monitoring: Identify key performance quality metrics and maintain a state of compliance
Continuous Improvement Oversight: Oversee continued improvement efforts

Relevant Information

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