Sr. Quality Assurance Specialist
The Senior Quality Assurance Specialist is a senior technical expert in Quality Assurance, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department and providing technical mentoring to the Quality Assurance staff. This role requires advanced technical knowledge in regulations and industry standards in the conduct of clinical trial operations with a strong understanding of research ethics and privacy.
Quality Planning, Execution and Oversight
• Develop, implement, and track compliance of QA plans (study, internal process and annual).
• Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders.
• Monitor, evaluate quality indicators, QA reports and audit responses.
• Support study operational teams with resolution of escalated issues.
• Identify quality GCP risks and work with leaders to design mitigation strategies.
• Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities.
Regulatory, Ethics and Privacy Support
• Act as a senior representative of Quality at internal and external meetings.
• Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics, and privacy inquiries.
• Remain knowledgeable and current on industry environment and regulatory legislation.
• Mentor other QA staff in the support of the development of standard operating procedures.
Technical Expertise Mentorship and Training
• Serve as a technical role model, motivator, and mentor to the members of the quality team.
• Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs.
• Develop and provide training both within the department and external to it.
Qualifications
• Minimum of a bachelor's degree with 7-9 years of related experience and on the go training
• Fluent in English (verbal and written)
• Certification in Quality GCP or Auditing with strong written and verbal communication and presentation skills.
• Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred.
• Strong analytical, critical thinking and problem-solving skills required.
• Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.
Working conditions
• Home-based
• *Accommodations for job applicants with disabilities are available
Apply Now
Apply Now
Quality Planning, Execution and Oversight
• Develop, implement, and track compliance of QA plans (study, internal process and annual).
• Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders.
• Monitor, evaluate quality indicators, QA reports and audit responses.
• Support study operational teams with resolution of escalated issues.
• Identify quality GCP risks and work with leaders to design mitigation strategies.
• Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities.
Regulatory, Ethics and Privacy Support
• Act as a senior representative of Quality at internal and external meetings.
• Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics, and privacy inquiries.
• Remain knowledgeable and current on industry environment and regulatory legislation.
• Mentor other QA staff in the support of the development of standard operating procedures.
Technical Expertise Mentorship and Training
• Serve as a technical role model, motivator, and mentor to the members of the quality team.
• Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs.
• Develop and provide training both within the department and external to it.
Qualifications
• Minimum of a bachelor's degree with 7-9 years of related experience and on the go training
• Fluent in English (verbal and written)
• Certification in Quality GCP or Auditing with strong written and verbal communication and presentation skills.
• Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred.
• Strong analytical, critical thinking and problem-solving skills required.
• Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.
Working conditions
• Home-based
• *Accommodations for job applicants with disabilities are available
Apply Now
Apply Now