REQUIRED QUALIFICATIONS

• Bachelor’s degree in Computer Science, Information Technology, or related field.
• 8+ years of experience in IT Quality within the life sciences industry or equivalent.
• Strong knowledge of GxP regulations, software validation, and Computer Software Assurance (CSA).
• Experience with Agile, Lean, and Waterfall development methodologies.
• Familiarity with automated testing tools and SAP-related platforms (e.g., Solution Manager and ALM,).
• Working knowledge of risk management, regulatory requirements, and industry best practices.
• Excellent analytical, organizational, and communication skills.
• Ability to lead in a fast-paced, dynamic environment with both strategic and tactical responsibilities.

PREFERRED QUALIFICATIONS

• Certifications in ASQ, ISO 9001, or ISO 13485.
• Experience in regulated environments and inspection support
• Strong mentoring and leadership capabilities.
  This is a unique opportunity to shape the future of IT compliance and quality in a global, regulated environment. If you are passionate about quality, innovation, and making a meaningful impact, we’d love to hear from you.

ABOUT THE ROLE

We are seeking a highly experienced and strategic Software Quality Assurance Manager to join our BTS IT Quality Operations team. In this pivotal role, you will lead quality and compliance initiatives across multiple BTS IT domains, ensuring alignment with regulatory standards and business objectives. You will serve as a subject matter expert in IT validation, software quality assurance, and compliance strategy, working closely with cross-functional teams including Software Quality, DevOps, and business stakeholders.
This is a global-facing role with significant influence over IT compliance strategy, validation methodologies, and continuous improvement programs. You will also mentor junior staff and lead contract teams, playing a key role in shaping a culture of quality and compliance across the organization.

KEY RESPONSIBILITIES

• Ensures IT validation packages comply with applicable Corporate and Divisional Policies and procedures.
• Works autonomously with related IT contacts and the business process SMEs for this purpose.
• Provide strategic consultation on IT Quality policies, procedures, and best practices.
• Coordinates the introduction of new strategic methodologies; supports and approves the overall validation of global regulated applications.
• Drives the GXP Inspection Support, defending validation strategies to auditors and regulatory bodies.
• Apply SQA engineering principles to identify defects and design flaws throughout the software lifecycle.
• Collaborate with development teams to embed compliance into deliverables and ensure business needs are met.
• Guide teams in risk-based decision-making using Quality Risk Management principles.
• Ensure adherence to Good Documentation Practices and support compliance documentation efforts.

SUPERVISORY RESPONSIBILITIES

• Direct Reports: 1–5 contract staff
• Indirect Reports: 1–5 contract staff