Software Validation Specialist

2 weeks ago

Manila, National Capital Region, Philippines SimplerQMS AS Full time
About the Role

As a Software Validation Specialist at SimplerQMS, you will take ownership of our software validation processes, ensuring that our platform and related products remain secure, compliant, and reliable. You will be part of our QA team and collaborate closely with cross-functional teams (e.g. Product and Customer Success) to plan, execute, and continuously improve validations in alignment with GAMP 5, ISO/TR 80002-2, ISO 13485, FDA 21 CFR regulations (including Parts 11, 820, 211, 212), Eudralex Volume 4 GMP Annex 11, GMP Part I, and the evolving FDA Computer Software Assurance (CSA) framework. By streamlining validation procedures, you'll help create a competitive advantage through faster release cycles, increased operational efficiency, and high-quality, audit-ready solutions.

What You'll Do

  • Develop and Maintain Validation Strategy: Plan and refine validation methodologies, test protocols, and SOPs in accordance with GAMP 5, CSA principles, and ISO requirements.

  • Perform Risk-Based Testing: Focus on critical software functions that impact patient safety, product quality, and data integrity, applying a risk-based approach (CSV/CSA).

  • Lead Documentation Efforts: Ensure traceability between requirements, design specifications, test cases, and risk assessments, maintaining clear, audit-ready records.

  • Ensure Compliance & Readiness: Stay updated on global regulations, lead validation activities during audits, and champion best practices across the company.

  • Drive Continuous Improvement: Identify opportunities to optimize processes, reduce unnecessary complexity, and scale validation frameworks that support product growth and rapid releases.

  • Collaborate & Train: Work closely with internal teams to advocate for CSA-aligned validation practices; provide training and guidance on new procedures or regulations.

Qualifications We're Looking For

  • Bachelor's or Master's degree in Software Engineering, Computer Science, or related field.

  • Strong familiarity with ISO/TR 80002-2, GAMP 5, ISO 13485, and FDA 21 CFR Parts 11, 820, 211, 212.

  • Proven experience conducting Computerized Systems Validation (CSV), with knowledge of FDA's CSA approach being a plus.

  • Ability to create and review validation documentation (IQ, OQ, PQ), test protocols, CAPA records, and risk assessments.

  • Excellent written and verbal communication skills, able to explain complex validation strategies to both technical and non-technical stakeholders.

  • Adaptable and proactive mindset, with a strong drive to keep up with shifting regulations and continuously optimize processes.

Personality & Culture Fit

At SimplerQMS, we live our values every day. We're looking for someone who is:

  • Passionate: Committed to delivering high-quality outcomes, with a genuine enthusiasm for learning and innovation.

  • Helpful: Eager to support teammates and stakeholders, building collaborative and positive relationships.

  • Respectful: Practices fairness and inclusivity; values diverse perspectives and open communication.

  • Customer-Centric: Understands customers' needs and prioritizes solutions that are easy to adopt and consistently reliable.

  • Quality-Driven: Maintains top-tier standards, adhering to established regulations and internal policies.

  • Efficient: Focuses on continuous improvements that boost productivity and keep validation processes lean and effective.

Why Join SimplerQMS?

  • Meaningful Impact: Help life science teams bring life-saving products to market with greater speed and compliance.

  • Remote-First Environment: We value talent and alignment with our mission—no matter where you live.

  • Growth Opportunities: Be part of a fast-growing scale-up that has recently secured its first funding round, accelerating product development and market expansion.

  • Collaborative Culture: Work alongside a supportive, purpose-driven team that believes in knowledge-sharing and constant improvement.

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