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.