Senior QA Manager, Computer System Assurance IT and Infrastructure APAC

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Singapore is looking for an expert in quality assurance to ensure compliance of computerized systems with global regulatory standards. The ideal candidate should hold a Bachelor's degree in Pharmaceutics, IS/IT, or Engineering, with over 5 years of experience in IT services and GxP regulated environments. This role involves providing expert guidance, managing validation strategies, and fostering a zero-accident mindset within teams.

Qualifications

• 5+ years of experience in IT or IT services.
• 3-5 years of experience in a GxP regulated environment focusing on quality assurance.
• Ability to prioritize and manage multiple tasks effectively.

Responsibilities

• Ensure compliance with global regulatory requirements for computerized systems.
• Provide guidance on validation strategies to business stakeholders.
• Manage internal and external resources for quality and compliance.

Skills

GMP requirements knowledge

Project Management

MS-Office proficiency

Strong communication skills

Ability to work in teams

Education

Bachelor’s degree in Pharmaceutics, IS/IT, or Engineering

Master’s degree (e.g. MBA, MSc) preferred

Job description

The Position

This role is critical in ensuring that global, local, cross-business, and cross-functional computerized systems meet both Boehringer Ingelheim’s internal quality standards and the validation/qualification requirements of global regulatory authorities.

As a key quality authority, you will be responsible for approving the implementation and ongoing maintenance of these systems, ensuring they remain in a validated state and compliant with evolving regulatory expectations. You will play a strategic role in shaping local, regional, and global organizational structures and processes that support IT applications, infrastructure, and system templates.

You will provide expert guidance on validation and qualification strategies, ensuring that both process and technical considerations are fully addressed. Your oversight will span the entire system lifecycle—from implementation to operations—including monitoring KPIs, conducting trend analyses, and initiating control measures or escalations when needed.

Additionally, you will manage internal and external resources to uphold the quality and compliance of all computerized systems within scope, making a direct impact on the integrity and efficiency of our global IT landscape.

Duties & Responsibilities:

• Ensure computerized systems within scope meet global regulatory requirements, including validation/qualification, GxP compliance, and electronic records/signature standards.
• Provide expert guidance to business stakeholders and project teams on validation strategies using the LeVa framework, including customized training and feedback for continuous improvement.
• Actively contribute to the CSV MSO Network and International CSV Working Group, addressing emerging technologies (e.g., cloud computing, mobile apps, AI, big data) and aligning with external regulatory expectations.
• Assess and qualify suppliers and providers of software, hardware, and cloud solutions to ensure compliance with Boehringer Ingelheim standards and regulatory requirements.
• Oversee validation/qualification concepts and strategies to address evolving technology environments, including agile development and innovative platforms.
• Support strategic initiatives and contribute to cross-organizational topics with potential broader impact, including risk-balanced cost and effort reduction.
• Foster a strong quality culture across teams and business partners, ensuring alignment with internal safety guidelines and promoting a zero-accident mindset.
• Represent Boehringer Ingelheim during audits and inspections, manage CAPA action plans, and ensure compliance through self-inspections and continuous process improvement.
• Review and approve relevant SOPs and ensure external contributors adhere to agreed methodologies, providing guidance and monitoring deliverables.

Requirements:

• Bachelor’s degree with major focus on Pharmaceutics and/or IS/IT and/or Engineering or equivalent experience in CSV Computer System Validation; Masters degree (e.g. MBA, MSc) is preferred
• Excellent knowledge of international GMP requirements, Quality systems, Quality management ( as applicable: 21 CFR Part 11, Annex 11, applicable GAMP and ISPE guides, etc.)
• Minimum of 5 years of experience in IT or IT services
• Minimum 3-5 years of experience in a GxP regulated environment with focus on quality assurance and/or computer system validation/qualification.
• Expertise in Project Management
• Well-founded knowledge in MS-Office
• Strong written and oral communication skills, ability to influence and manage upward, ability to work well in team environments.
• Ability to prioritize and to effectively manage multiple tasks at the same time
• Respect and understanding of cultural diversities across the area of responsibility
• Collaborative and integrated working style