Director/VP of QA/Regulatory Compliance—eClinical software
Location: Philadelphia (PA)
- WOULD YOU LIKE TO BE APART OF THE FASTEST GROWING CLINCIAL SOFTWARE COMPANY IN THE WORLD?
- WOULD YOU LIKE TO WORK FOR AND ORGANIZATION THAT WAS RATED ONE OF THE BEST PLACES TO WORK FOR?
- IF THIS IS WHERE YOU WANT TO SPEND THE NEXT 5 YEARS THAT PLEASE READ ON!
My client is a leading developer of software solutions for the life sciences industry. They have a very strong existing client base (Global Pharma) and have consistently over-achieved targets. This is a stable leader in the industry with a proven track record and consistent growth yr over yr with last growing 80%.
If you have experience in/and around EDC, Clinical Data Software, e-Patient Diary software, IVRS, ESubmissions IWR…etc you should send your information for confidential consideration to jhersh@kleinhersh.com We work with many of the leaders in the CRO and Clinical Software world providing sales talent.
DESCRIPTION:
- Provide guidance, interpretation, support, training, and key input to staff on interpretation of GCP regulations, guidelines, quality system requirements, corporate standards, and policies.
- Direct the development and implementation of training on new / enhanced SOP management processes.
- Provide expertise as needed to customers during the development of new SOPs.
- Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
- Act as customer liaison during audits of SOP Management.
REQUIREMENTS:
- Must have GCP experience
- Must have experience coming from clinical software background ( EDC, ePRO, IVRS )
- Bachelor's degree in life sciences with 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience.
- A minimum of 3 years of management experience
- Experience in SOP Management / Document Control and SOP writing
- Knowledge of process improvement and project management methodologies.
- Strong technical / medical writing skills including knowledge of SOP writing.
Compensation:
100-150K Base Salary (negotiable on background)
Excellent Benefits…etc.
Please email a word document of your resume to jhersh@kleinhersh.com In the body of the email, outline your Clinical software background according to the requirements in this email.
Visit www.kleinhersh.com to view additional job opportunities available through our company.
