Associate Director Clinical Quality Assurance
Há 1 mês
Job Description
Support the implementation and management of the Quality assurance strategy across multiple studies and/or countries. Utilize audit and inspection intelligence and risk mitigation plans to ensure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.
This role is responsible for executing global Quality Assurance audit activities on assigned studies, products, vendors, and Country Offices. Accountable for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight; ensuring compliance with Company's Standard Operating Procedures, policies, and all applicable worldwide regulations and guidelines.
Primary activities include:
- Conduct Quality Assurance audits, generate audit reports, communicate results to relevant QA management and external stakeholders, and ensure corrective and preventative actions are taken;
- Perform Good Clinical Practice (GCP) and Pharmacovigilance (PV) audits, provide QA guidance, and represent QA as a single point of contact;
- Provide GCP compliance advice, proactively identify quality indicators and risks, support audit scheduling, and contribute to quality oversight initiatives;
- Analyze data, identify trends, perform root cause analyses, manage quality issues, ensure compliance, and promote standardization within QA;
- Develop QA procedures, guidance documents, audit tools, and participate in special assignments determined by QA management.
Main requirements:
- Bachelor's degree or higher in pharmacy or a life-science subject;
- Extensive knowledge of drug development process, Good Clinical Practice guidelines, and regulations;
- Experience as a clinical quality professional, with auditing experience considered a plus;
- Business Acumen and Attention to Detail;
- Logic, analytical skills, effective communication, and creative thinking.
We value diversity and innovation:
We promote an inclusive environment where diverse ideas lead to breakthrough innovation. Encouraging respectful challenges and collective problem-solving. We are committed to fostering an inclusive and diverse workplace as an equal opportunity employer.
Do Not Contact:
This company does not accept unsolicited assistance from search firms for employment opportunities. CVs submitted without a valid written search agreement will not be considered.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
Shift:
1st - DayValid Driving License:
YesHazardous Material(s):
n/aJob Posting End Date:
05/31/2024*Job Posting End Date:05/31/2024
A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date.
Requisition ID:R270167
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