Manager, QA Validation system

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

Job Description

About the role

Works closely with and have impact on: IT, ME, Supply Chain, Production, RA

Reports to: Senior Manager, QA Labeling and Projects

Function: Global QA and Compliance

Role Overview

This position is a global position that oversees development, implementation, and management of Quality Assurance (QA) validation systems, acting as the Subject Matter Expert (SME) for overall Computerized System Validation (CSV) program.

He/she will drive validation strategy and ensures compliance with regulatory requirements for computerized systems, as well as collaborating with IT function on CSV execution and CSV deliverables.

Duties and Responsibilities

• As the QA SME for overall CSV program, practices and processes, ensuring its design and implementation comply with regulatory or standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
• As primary QA point of contact for CSV strategy
• Establish and maintain Computerized System Validation Master Plan (CSVMP) and oversee periodic reviews and updates
• Lead QA review and approval of CSV-related documentation, including validation protocols, risk assessments, and reports
• Conduct gap analysis and risk assessments to identify and mitigate compliance issues in computerized systems
• Provide regulatory oversight by ensuring all validation activities adhere to regulatory requirements, including Good Automated Manufacturing Practices (GAMP) and Good Manufacturing Practices (GMP)
• Provide guidance and QA oversight on CSV projects, ensuring seamless coordination and alignment between QA and IT
• Collaborate with IT to ensure proper planning, validation, and lifecycle management of computerized systems, including ERP, MES, and e-QMS
• Support execution and documentation of CSV Program including user requirement specification (URS), risk assessments, functional/design specifications (FS/DS), configuration specifications (CS), test scripts, requirement traceability matrix (RTM), validation summary report (VSR), qualification protocols and reports, periodic system maintenance and compliance reviews.
• Support IT to ensure data integrity and system compliance through robust validation practices
• Identify opportunities to enhance efficiency and effectiveness of CSV program and overall validation processes and adopt best practices in validation
• Develop a culture of data integrity excellence by ensuring appropriate systems and processes are in place to support GMP data integrity.
• Continuously improve data integrity knowledge base, identify training needs with appropriate training materials, and engage communications with stakeholders to strengthen quality culture
• Support development and implementation of data control strategy for manufacturing and laboratory equipment
• Support software supplier audit as SME

Requirements

Experience

• Minimum of 8-10 years of experience in quality assurance and validation, especially on computerized system validation (CSV), within medical device or pharmaceutical or biotechnology industries
• Proven expertise in developing and managing CSV programs in GxP-compliant environment, with strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11
• Experience working collaboratively with IT and other stakeholders with proven track records to ensure successful CSV execution
• Experience with regulatory inspections and audits
• Proficiency in quality management systems (QMS) and validation tools
• Proficiency in validation lifecycle documentation, including VMP, URS, FD/DS, CS, VSR, risk assessment and validation protocols
• Experience with software development lifecycle (SDLC) methodologies
• Leadership experience in cross-functional and global team environments is an added advantage

Skills/Accreditations

• Strong understanding of validation principles, risk management, and data integrity requirements
• Ability to make informed decisions and work well with different stakeholders
• Excellent analytical, problem-solving, and project management skills
• Exceptional communication and collaboration skills to bridge QA and IT
• Detail oriented, with strong good documentation practices expertise
• Self-motivated and able to work independently

Academic Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Information Technology, Computer Information Systems, Information Systems Technologies, or related field.

Travel requirements

• Up to 30% depending on project