Senior Quality Assurance Specialist

hace 1 semana

Buenos Aires, Argentina Syneos Health A tiempo completo
Senior Quality Auditor Job Description

We are seeking a highly skilled Senior Quality Auditor to join our team at Syneos Health. As a Senior Quality Auditor, you will be responsible for conducting GxP audits and other services such as CAPA management or consulting activities.

Key Responsibilities:
  • Schedule, conduct, and document assigned audits of projects in accordance with approved procedures, schedules, and formats.
  • Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc.
  • Expertise in management of deviations and Non-Conformities (NCs); RCA and CAPA process based on FDA, EMA, MHRA requirements specifically focused on GCP.
  • Work in a defined, robust, and documented end-to-end deviation and CAPA management process.
  • Able to determine if the investigation is commensurate with the significance and risk and determine if appropriate actions have been taken and were effective.
  • Ability to plan, organize, and effectively communicate with customer stakeholders in the investigation, building a rapport with the team.
  • Maintain accurate and timely documentation of QA auditing activities.
  • Serve as a trainer and mentor to newly hired QA Auditors.
  • Maintain subject matter expertise through training, review, and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
  • Participate in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.
Requirements:
  • Demonstrated initiative, uncompromised integrity, and a results-oriented mindset.
  • Bachelor's Degree in the science/health care field or equivalent combined education and experience.
  • Extensive experience in clinical quality assurance auditing (GCP) and conduct of vendor audits (e.g., of central laboratories, clinical suppliers, IRBs, etc.).
  • Strong knowledge of all applicable Good Clinical Practice (GCP) regulations and guidelines.
  • Good Pharmacovigilance Practices (GVP) clinical safety and post-marketing auditing experience, preferred.
  • Knowledge of medical terminology, preferred.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment.
  • Strong organizational, presentation, documentation, and interpersonal skills with diverse cultures.
  • Ability to negotiate and provide constructive feedback.
  • The ability to travel up to 50% (though for CAPA management and other remote activities, travel is not required).

At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles.

We are a global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Join our team and be part of the big picture. Collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy.

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled).

We have a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.

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