Quality Assurance Manager

Position Overview:

The Quality Assurance Manager will lead the transformation of QA processes from manual to automated testing, ensuring compliance with regulatory standards and driving innovation in a regulated healthcare environment. This role requires a strong software engineering background to build automation frameworks, lead testing strategies, and collaborate with cross-functional teams to deliver high-quality IT systems.

Key Responsibilities:

• Develop and implement QA strategies and frameworks aligned with clinical industry standards (e.g., FDA, GxP, HIPAA).
• Lead and mentor QA teams, fostering a culture of quality, innovation, and continuous improvement.
• Transition QA processes from manual to automation, building and maintaining scalable testing frameworks and automation pipelines.
• Collaborate with development, operations, and compliance teams to address quality gaps and implement corrective actions.
• Manage validation and verification processes for clinical IT systems, ensuring data integrity, security, and compliance.
• Conduct risk assessments, root cause analyses, and audits related to IT QA.
• Report QA metrics and actionable insights to senior management to drive continuous improvement.

Qualifications:

Required:

• Bachelor’s degree or equivalent experience in IT, Computer Science, or a related field.
• 5+ years of experience in IT QA, preferably in regulated industries.
• Expertise in manual and automated testing frameworks and tools.
• Proficiency in programming/scripting languages (e.g., Python, Golang, R scripting).
• Proven leadership skills and the ability to collaborate across teams.

Preferred:

• Experience with LIMS, CTMS, or EDC systems.
• Certifications in QA or regulatory compliance (e.g., ISTQB, CQA).
• Healthcare, pharmacy, or bioscience background (not required but nice to have).

Why Join?

• Make a Difference: Lead the transformation of QA processes, driving innovation and efficiency in a critical and impactful role.
• Exceptional Pay & Benefits:
• Competitive salary with 20% bonus potential.
• 20 PTO days annually.
• 401(k) with 100% company match up to 6%, no waiting period.
• Low-cost health care plans with HSA contributions.
• Company stock grant upon hire.
• Growth Opportunity: Be part of a growing company with the opportunity to shape QA processes and frameworks.
• Culture: Collaborative, supportive, and focused on teamwork with a "no jerks allowed" policy.
• Flexibility: In-office role with work-life balance and occasional travel (1-2 weeks per year).

Schedule:

• Monday–Friday, 9:00 AM–5:00 PM (40 hours per week). With Work Flexibility
• Based in Phoenix, AZ.