about 1 year ago
Start working for a clinical stage biotech company in San Diego, CA. The company is developing products for the treatment of rare diseases using a combination device/drug prodct.
The position requirements include:
· Manage processes assocaited with Quality Systems for all generic good practice areas.
· Manage processes assocaited with Phase-appropriate worldwide QA strategy covering cGMP/QSR's (drug and device), and GCP
· Oversee supplier and vendor management including qualification, auditing and on-going Quality Management
· Perform batch reviews and release of Clinical Trial Materials.
· Construct SOP's, oversee training.
· Experience in achieving "Inspection Readiness" for GMP and GCP areas
· Lead QA support during internal and external audits
· Review technical documents and agreements from QA perspective
Candidate background and experience:
· 10 years of experience initiating and implementing Quality Systems (investigational pharmaceutical products).
· Experience with developing phase-appropriate QA strategy that would be compliant with US and EU requirements, and successfully implementing it
· Experience with Quality Systems relating to the development of a drug/device combination product would be highly desirable
· Experience working in a virtual environment
Education and skills
· BS/MS/PhD in a Science or related filed
· Proven leadership skills
· Flexible in approach to overcome obstacles that meet all Quality requirements.
· Excellent communication skills.
· Excells in a high-paced environment typical of early stage companies.
· Requires williness to use skills ranging from strategic thinking to hands-on drafting of quality documents.