WHAT DOES A QUALITY ASSURANCE MANAGER DO?

The Quality Assurance Manager evaluates functional and non-functional requirements for testability and suitability for automation, including code reviews and best practices recommendations. Applies automated tools across all phases of the Software Development cycle, while supervising and managing QA teams of 5-20 members on various scrum teams. Monitors project quality health, recommends tools and processes for development strategy and drives initiatives to enhance team productivity and CI/CD processes.

A Review of Professional Skills and Functions for Quality Assurance Manager

1. Quality Assurance Manager Duties

  • Quality System Development: Development, implementation, and enforcement of all established policies and procedures.
  • COA Review: Reviews all COAs received for ingredients and raw materials to ensure compliance with published product specifications.
  • Label Verification: Verifies that all active labels meet all legal requirements.
  • Specification Management: Develops, updates, and maintains product specifications for all ingredients, primary packaging supplies, and finished goods.
  • Product Disposition: Determines disposition for all products placed on HOLD and verifies conformance to that disposition.
  • Food Defense Program: Develops, updates, and maintains the Company's Food Defense Program.
  • HACCP Plan: Develops, reviews, implements, updates, and enforces the HACCP plan.
  • Food Safety & Quality: Identifies food safety culture and quality non-compliances or possible improvements.
  • Corrective Actions Reporting: Reports instances of non-compliance to ensure corrective actions can be taken to rectify the immediate situation and prevent recurrence.
  • Business & Information Prioritization: Works with management to prioritize business and information needs.

2. Quality Assurance Manager Details

  • Quality System Management: Develop, implement, and maintain Quality System processes and procedures including CAPA, risk management, non-conformances, change control.
  • Leadership: Provide leadership and support to document control specialists in the management.
  • Document Control: Control of QMS documents and records to ensure preparation, control, review, and approval is performed on a timely basis.
  • Internal Audits: Schedule, plan, and perform internal audits in accordance with an approved schedule and monitor corrective actions.
  • Quality Reviews: Perform detailed and thorough quality reviews to ensure data integrity, internal content consistency, and completeness on a wide range of regulatory deliverables (e.g., CSRs, IBs, CTDs, PK reports, etc.).
  • Policy Development: Participate in the development and/or revision of internal policies and procedures.
  • Quality Training: Respond to general Quality questions, train stakeholders on the review process and expectations, and remain current with industry Quality standards.
  • Stakeholder Collaboration: Collaborate with internal and external stakeholders in a manner that maintains an open and welcoming working relationship.
  • Data Analysis: Use multiple data sources and trend analysis with the intent to identify design and manufacturing weaknesses for resolution.

3. Quality Assurance Manager Responsibilities

  • Quality Assurance Leadership: Leading, directing, managing, and coordinating the Quality Assurance activities onsite supporting the manufacture of large IVD instrumentation.
  • Quality Commitment: Achieving and sustaining a focus on and commitment to Quality in the manufacture of products and services.
  • Process Measurement: Driving process measurement initiatives, including scorecards and other metrics, which can also be used to drive process improvements.
  • Team Management: Managing a team of Quality Assurance professionals acting as an SME and Technical expert within areas of responsibility.
  • Team Development: Lead, mentor, and develop the team in deploying, managing, and improving processes.
  • Customer Focus: Strong customer focus to understand customer requirements appropriately to meet customer expectations and to identify relevant KPIs for quality oversight.
  • Customer Integration: Regular customer integration should be fostered with consequent usage of feedback tools, as well as professional feedback.
  • Complaint Handling: Focus on complaint handling to achieve high customer satisfaction and retention.
  • Escalation and Root Cause Analysis: Clear escalation with fast complaint routing and consequent root cause analysis to satisfy the customer.
  • Collaborative Quality Assurance: Collaborating with the production and engineering teams onsite for Quality Assurance related activities, initiating continuous improvement in order to consistently fulfill the expectations and needs of customers.

4. Quality Assurance Manager Job Summary

  • Data Analysis: Collect, track, and analyze data to detect quality deficiencies, duplicated effort, or non-compliance with regulations.
  • Investigations & Corrective Actions: Conduct investigations, report findings, and establish corrective actions based on all findings.
  • Regulatory Compliance: Ensure compliance with all standards, policies, procedures, and documentation requirements set by DKMS, registries, and regulatory authorities.
  • Process Improvement: Plan, coordinate, and monitor process improvement projects.
  • Quality Management: Maintain the Quality Management Program and develop and guide organizational quality initiatives.
  • Problem Resolution: Maintain and improve processes for problem form resolution and error correction processing.
  • Staff Training: Educate and train staff on compliance, privacy, and good documentation practices.
  • Regulatory Registration: Maintain, submit, and renew DKMS registration with all applicable regulatory agencies (e.g., FDA, FWA, DOH, registries).
  • Employee Training & Vendor Contracts: Maintain user profiles, provide new employee training, and maintain contracts with vendors.
  • Program Validation & Documentation Management: Conduct ongoing validation for both programs and manage all controlled documentation via eQMS.
  • Document Compliance: Ensure that all documents are in compliance with all standards, policies, and procedures.

5. Quality Assurance Manager Accountabilities

  • Documentation Compliance: Documentation requirements set by DKMS, registries, and regulatory authorities.
  • Document Control: Approve document control changes and communicate process updates to employees.
  • Standardized Formatting: Ensure standardized formatting of all new materials prior to approval.
  • Internal Audits: Perform annual internal process audits to ensure that DKMS is in compliance with all Standard Operating Procedures and regulatory standards.
  • SOP Management: Oversee the annual review and updates of Standard Operating Procedures (SOPs).
  • Policy Modification: Oversee recommendations of modifications to existing procedures or policies.
  • Documentation Enhancement: Enhance documentation and clinical data collection processes.
  • Data Collection Assistance: Assist with processing clinical data collection forms to meet mandated quarterly CPI submission deadlines.
  • Donor Chart Audits: Conduct monthly audits of donor medical charts and document all related process deviations.
  • HIPAA Compliance: Ensure that the office and its employees are in compliance with HIPAA requirements by providing training and updates.

6. Quality Assurance Manager Functions

  • Medical Supply Control: Oversee medical supply control and environmental monitoring, liaising with privacy legal experts.
  • Training Record Management: Track and trend employees’ training records via eQMS.
  • Training Course Development: Create and re-approve electronic training courses for updates to controlled documents as well as new NMDP-mandated processes and documents.
  • Retraining & CAPA Oversight: Deploy retraining in relation to CAPA and oversee internal audit processes.
  • External Quality Inquiries: Contact for all external quality inquiries and investigations.
  • Quality Incident Investigation: Investigate and document all quality incidents and SOP deviations, maintaining monthly summaries.
  • Adverse Event Reporting: Oversee documenting and reporting Adverse Events to NMDP.
  • SEARs & SPEARs Tracking: Track SEARs and SPEARs in accordance with World Marrow Donor Program expectations.
  • Vendor Qualification & Audits: Oversee annual vendor qualification and external audits of vendors.
  • Vendor Onboarding & Agreements: Assist with onboarding and qualification of new vendors, as well as institution of Business Associate Agreements. 

7. Quality Assurance Manager Job Description

  • Operational Procedure Approval: Approve all operational procedures/instructions, specifications, and master production instructions with the potential to affect product quality.
  • Validation Review: Review and approve validation protocols and reports, study protocols, and reports to support capital or key site projects.
  • Stability Data Management: Ensure stability data supports retest or expiry dates and storage conditions.
  • Inspection & Audit Support: Support inspections and audits from external parties (e.g., FDA, IMB, EMEA, or alliance partners).
  • Regulatory Dossier Preparation: Prepare and review regulatory dossiers.
  • Quality Systems Oversight: Oversee quality systems such as CAPA, ER report system, Change Review Board system, etc.
  • Staff Appraisals: Complete the annual appraisals of QA operations staff and ensure stretch goals and appropriate learning and development goals for each.
  • Material Release System: Establish a system to release or reject raw materials, intermediates, packaging, labeling materials, and finished products.
  • Annual Product Review: Prepare and approve the Annual Product Review, including data collection and graphic analysis.
  • Contract Documentation Maintenance: Maintain contract documentation, including Universal Procedures of Interaction with apheresis and collection centers.

8. Quality Assurance Manager Overview

  • QA Support: Provide QA support for the manufacture of products to ensure compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures, and business requirements.
  • Project Management Participation: Participate in appropriate project management meetings to stay informed of ongoing activities.
  • GMP Compliance: Identify and address any gaps relating to product quality and GMP compliance, including new CMO site selection, new product introductions, and territory expansion.
  • Technical Agreement Preparation: Prepare and maintain Technical (Quality) Agreements with third-party contractor manufacturing organizations (CMOs) to clearly define and implement roles and responsibilities.
  • Batch Record Review: Review completed production batch records, approve master batch records, and other cGMP documents from CMOs/Contract Laboratories before releasing the product for sale and distribution.
  • Non-Conformance Review: Regularly review non-conformances (e.g., process deviations, out-of-specification/trend results) at the CMO.
  • CAPA Implementation: Ensure resulting investigations have identified root causes, suitable reports have been written, and corrective and preventative actions (CAPAs) have been implemented within suitable time periods.
  • UK QA Contact: Act as the UK QA point of contact for the importation of all products imported from the EU to the UK under the RPI scheme.
  • Validation Protocol Review: Carry out the review and approval of validation protocols and reports during technical transfer and process change activities.
  • Process Validation: Ensure manufacturing processes and analytical procedures at the CMOs operate in a validated state.

9. Quality Assurance Manager Details and Accountabilities

  • Change Control Management: Ensure that all changes to GMP documents, processes, equipment, and facilities are effectively managed through the CMO and KKI change control processes to maintain GMP and regulatory compliance.
  • Complaint Response Management: Ensure that an appropriate response has been provided by the CMO following an investigation into customer complaints and that corrective and/or preventative actions have been implemented at the CMO facilities.
  • Customer Complaint Review: Review customer complaints and reports to ensure that an appropriate response has been provided following an investigation.
  • Corrective Actions Implementation: Implement corrective actions at the third-party contractor facilities.
  • Defective Product Review: Actively participate in the review and recall of defective products to minimize patient risk.
  • Product Quality Profile Maintenance: Ensure that for each product, a Product Quality Profile is maintained and provided, where relevant, to the CMO’s Qualified Person (QP) so that the product can be manufactured, controlled, and released in compliance with the Marketing Authorisation.
  • SOP Review: Review departmental standard operating procedures (SOPs) impacting GxP for content and compliance with appropriate regulatory requirements.
  • Stability Program Management: Ensure that GMP stability programs are established, implemented, and regular reports are issued by the CMO(s), and that trends in data and confirmed out-of-specification results are investigated and reported to QA management in compliance with cGMP and regulatory requirements.
  • Performance Reporting: Provide regular reports of key performance indicators to senior management as part of the Quality System, so that the appropriate resources can be allocated and corrective actions implemented.

10. Quality Assurance Manager Duties

  • Testability Evaluation: Evaluate the functional and non-functional requirements for testability and the test cases and use cases for suitability for automation.
  • Code Review: Code review for automation cases and suggest best practices and frameworks to the team.
  • Automated Testing: Apply automated tools to support the testing of applications across all phases of the Software Development cycle.
  • QA Team Management: Supervise and manage QA teams of 5-20 QAs on various scrum teams simultaneously.
  • Quality Monitoring: Monitor and track the quality health of the assigned project and develop strategies.
  • Quality Improvement: Improve quality and maintain a high level of quality for the project.
  • Tool & Process Research: Research and recommend tools and processes to support the development strategy in the Quality area.
  • CI/CD Process Management: Establish, maintain, and control CI/CD processes and drive them to success.
  • Productivity Improvement: Drive initiatives to improve team productivity.
  • Distribution Process Support: Support the distribution processes for all products under the guidance of the RP and in adherence to GDP.