Quality Assurance & Compliance Manager

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. 

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.

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 Good x Practice (GxP) subject matter expertise, preferably in Clinical, Pharmacoepidemiology or Manufacturing.
• 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. 

About IOMED 

IOMED is a technological company of software development. It was launched in 2016, funded by local and international ventures.

We are passionate and talented young professionals, from all around Spain and the world (It couldn’t be any other way, as we’re based in beautiful and bright Barcelona). Our “dream team” is made up of mathematicians, statisticians, bioinformaticians, and physicians.

We are looking for people who are eager to innovate and be part of a project with an impact on the healthcare industry, enjoying what we do, team-work, and taking on new challenges.

IOMED is an equal opportunity employer. We are still a small team and are committed to growing in an inclusive manner. We want to augment our team with talented, dynamic people irrespective of race, color, religion, national origin, sex, physical or mental disability, or age.

What we do 

Nowadays, around 50% of Clinical Trials are delayed due to patient recruitment, since patient data collection is performed in a manual fashion. As a result, clinical research is highly inefficient both in time and cost, taking years and billions of dollars to develop a new drug.

This problem could be solved through Real World Data, i.e. derived from Electronic health records (EHR). But unfortunately, up to 85% of existing clinical data is unstructured, i.e. in plain text. This also leads, in part, to the existence of data silos, making it impossible to aggregate data from different hospitals.

IOMED has found the solution to this situation, making it possible to take advantage of the full value of clinical Real World Data. We developed a tool that extracts the necessary data from clinical texts, which results in a structured, standardized, and interoperable database that contains the complete clinical information from hospitals.

By this means, non-reusable information is transformed into data available for Clinical Research, allowing an enormous increase in criteria-compliant patients and a reduction of total time and manual labor devoted to this task.