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Headlands Research

Headlands Research is improving patients’ lives by advancing innovative medical therapies.

Director, Clinical Quality Assurance

QA EngineerQA EngineerFull TimeRemoteLeadTeam 201-500Since 2018H1B No SponsorCompany SiteLinkedIn

Location

Florida

Posted

6 days ago

Salary

Not specified

Seniority

Lead

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

• Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement. • Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada. • Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives. • Conduct and/or oversee annual and monthly quality reviews. • Support the corporate development team through quality review of potential acquisition candidates.

Job Requirements

  • Education - bachelors-degree in business or a health-related field required; master’s degree preferred
  • 5 years’ + experience in clinical trials industry (sponsor or site) with experience in managing quality
  • 3+ years’ experience leading a team
  • Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
  • Strong written and verbal communication skills
  • Exceptional organizational skills, ability to multi-task and be detail oriented
  • Ability to maintain high degree of professionalism and integrity.

Benefits

  • Health insurance
  • Retirement plans
  • Professional development

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