Quality Assurance

About the job

We're looking for a seasoned Quality Assurance Professional to help us accomplish our mission to improve clinical research. Here's what you need to know about the role, our team, and why IOMED is the right next step in your career.

About you

You're an Operations or Quality Manager with 4+ years’ experience in an operations or quality role and 1+ years’ experience managing people. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems every day. You’re a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.

Tareas

Tasks

You will help lead the Quality Management and Compliance (QMC) team in the development and execution of strategy for GxP Quality Assurance programs across IOMED’s software and research products and services. You will be responsible for strengthening, further developing and executing the quality assurance program and management systems in support of Flatiron programs. You will:

- In partnership with other team leaders, define and drive the strategy to continuously improve the QMS to support adherence to the applicable regulatory requirements and enhance the quality system utilizing a risk-based, fit-for-purpose approach.
- Lead teams, and develop programs that support the quality infrastructure including document and training management; audit/inspections programs; CAPA management; quality metrics; and QA support to project teams/programs.
- Develop and oversee the quality system and key metrics of quality activities (e.g. document management, vendor compliance management, CAPAs, internal audits, etc.) to ensure it continuously meets regulatory and business requirements. Develop reporting tools and metrics for communication to senior leadership.
- Develop and lead implementation of risk-based fit-for purpose Quality Assurance (QA) activities focused on risk assessment; issue identification, escalation, management; and corrective/preventive action (CAPA) management, and continuous improvement.
- Serve as a senior quality consultant/advisor to teams and leadership providing quality advice regarding topics such as: interpretation of applicable regulatory requirements; research best practices; document management; process development/improvement; audit and inspection readiness; and risk management.
- Gain constituency for improvements/change through engagement and partnership with cross-functional teams and leadership.
- Lead external audit/regulatory authority inspection program, including liaising with clients, hosting on-site visits, and internal facilitation/oversight of associated action plans.
- Develop and oversee the internal audit program focused on identifying gaps, risks and opportunity for improvement.
- Coach, lead, and mentor direct reports and build a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
- Foster a quality culture focused on meeting high quality, ethical and regulatory standards.

**Requisitos**:
What we are looking for
- You have a Bachelor's Degree (preferred in a relevant area, e.g., healthcare, quality, operations).
- You have strong project management, organizational, and analytical skills.
- You have direct experience planning, conducting, and supporting internal audits, external audits, and health authority inspections.
- You have substantial experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
- You have excellent verbal and written communication skills with demonstrated success working cross-functionally.
- You have some SQL skills, adept at data analysis and commitment to making data-driven decisions.
- You have a problem solving mindset and demonstrated ability to deliver results; ability to distill complex issues and translate them into concrete action plans.
- You have prior experience with root cause analysis, risk assessment, quality metrics, and corrective actions.

Nice to have
- You are comfortable working with remote teams and operating in a fast-paced, growing technology environment.
- You have experience with or an understanding of scientific methodologies or statistics.
- You have experience with clinical research, especially in the community oncology or clinical trials network setting.
- You have experience in epidemiological or outcomes research (real-world evidence)
- You have familiarity with data generated from EMR/EHR.

What we offer
- Full-time permanent contract.
- Competitive salary.
- Flexible schedule, with the possibility of home office once a week.
- A warm, transparent and supportive team, with a huge emphasis on work-life balance.
- The opportunity to make your mark in e-health and AI.