Technical Manager III
1 DNA Way South San Francisco, California 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Facilitate and document resolution of issues identified with quality system data content.
- Collaborate and communicate proactively with local/global sites as needed to ensure report accuracy.
- Assist in modifying format and content of quality reports and achieve compliance with company procedures and applicable regulations.
- Provide support to team members to process stakeholder' s feedback on quality reports.
- Collect, analyze and report metrics as needed.
- Support department to meet corporate goals and department objectives.
- Trackwise, Excel, PowerPoint and Word experience required.
- Sound knowledge of Quality Systems is essential and a good understanding of cGMP regulations is required.
- Strong time management skills and ability to prioritize own work.
- Experience reviewing documentation (quality checks).
- Excellent written and verbal communication skills.
- Strong interpersonal, influence, initiative, task management and negotiation skills.
- Ability to manage multiple, changing priorities in a fast-paced environment is essential.
- Strong attention to detail is required.
- 4-6 years pharmaceutical experience is required.
- At least four years direct experience in quality assurance for pharmaceutical operations is strongly preferred.
- BS or BA in a relevant scientific discipline or equivalent and demonstrated working knowledge of quality assurance and manufacturing principles.