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