What are the responsibilities and job description for the Clinical Development Quality Lead position at ASK Consulting?
- Job Type:Contract
Posted about 8 hours ago
- Expiry Date: 30 December 2023
- Referral: 234115@accuick.com
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Description:
Required Skills:
10 plus years of background, knowledge, and experience in the (bio) Pharma industry and applicable technical aspects of the business.
3 to 5 years of previous experience in Clinical Quality within a CRO or in a Pharma
Include specific skills, behaviors, and knowledge necessary to meet the objectives of the role
In-depth knowledge and understanding of ICH-GCP, and applicable regulations (domestic and international), quality principles, inspection preparation and hosting, risk management, and relevant business processes and techniques.
Knowledge and interpretation of GCP regulations and standards, with an understanding of the phase-appropriate application of GCP expectations.
Direct experience with FDA and/or EMA or other health authority inspections of the sponsor, investigator site(s), and/or CRO(s).
Self-motivated with the ability to take initiative, and ownership and manage responsibilities while shifting priorities quickly under tight timelines.
Strong analytical skills, problem-solving techniques, and understanding of ensuring a level of effort to address observations/quality issues are commensurate with
Roles and Responsibilities:
Looking for an experienced Clinical Quality Assurance professional to support inspection readiness activities for key clinical program. This role will involve working cross-functionally with internal departments and external organizations, such as CROs, to resolve quality issues to ensure inspection preparedness. Specific responsibilities will include:
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.
Salary : $83,400 - $106,000
