INACTIVE
Full-Time
Associate Director
Quality Systems
Posted on 4/18/2024
Develops cortisol modulation technologies for diseases
Biotechnology
Compensation Overview
$183,000 - $215,000Annually
Senior, Expert
Menlo Park, CA, USA
Required Skills
Communications
Quality Assurance (QA)
Requirements
- Experienced and well versed in System Development Lifecycle (SDLC)
- Working knowledge of Veeva Quality Suite, LMS systems
- Direct involvement and experience with regulatory inspections and audits
- Large system implementations leading cross-functional groups
- Acumen and comfort in persuading and influencing others at various levels of the organization
- Vendor evaluation and selection process
- Knowledge of principles for software validation and GAMP 5
- Excellent meeting facilitation and skills
- Excellent written and oral communication skills
- BA/BS in a scientific discipline
- Strong knowledge of GCP and GMP requirements including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and specific regulatory authority requirements (FDA, EMA, PMDA, etc.)
- 10 years’ experience in pharmaceutical QA, including in a hands-on system role
- Experience in working with enterprise systems
Responsibilities
- Prioritize and manage software projects including overseeing daily technical operations
- Achieve quality and GxP objectives while effectively balancing competing priorities and potential compliance risks with ongoing projects
- Support cross functional partnerships by delivering phase appropriate solutions for Corcept’s quality management system
- Recognize and assess opportunities that promote QA’s ability to deliver innovative solutions that support Corcept’s growth and evolving business needs
- Work with SMEs to develop controls and set management standards for system environments, while managing vendor relationships and licenses in line with Corcept’s growth
- Support Inspection Readiness objectives by identifying risks and implementing fixes or developing risk strategies
- Mentor the Quality Systems team with development opportunities and ensuring the team’s capabilities meet Corcept’s future needs
- Implement improvements to GXP Standard Operation Procedures (SOPs)
- Support regulatory authority inspections, including by coordinating cross-functional partners, in inspection preparation, hosting and responding to observations
Corcept Therapeutics specializes in developing selective glucocorticoid receptor antagonists to address the adverse effects of excess cortisol in a range of diseases, with a primary emphasis on creating a new generation of compounds aimed at mitigating the effects of excess cortisol in various diseases. Their focus is on cortisol modulation technologies for endocrine, metabolic, oncologic, and psychiatric disorders, with a pipeline of over 30 ongoing studies.
Company Stage
IPO
Total Funding
$119.1M
Headquarters
Menlo Park, California
Founded
1998
Growth & Insights
Headcount
6 month growth
↑ 10%1 year growth
↑ 19%2 year growth
↑ 42%INACTIVE