Associate Director, Quality Systems
Location
Menlo Park, CA | United States
Job description
At Corcept Therapeutics, we believe the potential impact of cortisol modulation on the future of health has long gone overlooked. That is why for twenty-five years we have pushed the boundaries of what is possible, driven by fiercely independent science, open collaboration and the curiosity to follow the data wherever it leads.
Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee. Our vibrant community is made up of over 300 people-medical practitioners, scientists, and industry professionals-all with the shared goal of advancing the science of cortisol modulation to treat serious disease.
Our work has uncovered over 1000 proprietary selective cortisol modulators, including our marketed product, Korlym ® (mifepristone), the first treatment available for those living with Cushing's syndrome, a life-threatening condition caused by excess cortisol activity. Today, we have a unique opportunity to revolutionize the treatment of severe endocrine, oncology, metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them.
This Corcept Quality Systems leader will have primary responsibility for prioritizing and managing Quality Assurance (QA) and GxP computer systems projects. These responsibilities include daily technical operations, strategy development, project management, and resourcing. Projects include software enhancements and maintenance, new implementations, and other continual process improvements for Corcept. This is a hands-on role requiring technical expertise (system development lifecycle and computer system validation) software and technical project management talent, and proven leadership competence.
The role will support all Corcept's quality and GxP operations and require collaboration with stakeholders across all levels of seniority. This will require the ability to recognize business improvement opportunities, evaluate urgency and diligently prioritize the project queue. Candidates should possess effective meeting facilitation skills, proficiency in project prioritization, and stakeholder expectation management. Because QA supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.
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.
Preferred Skills, Qualifications and Technical Proficiencies: - Experienced and well versed in System Development Lifecycle (SDLC)
- Working knowledge of Veeva Quality Suite, LMS systems
- Hands on configuration experience
- 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
Preferred Education and Experience: - 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
The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,000 - $215,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
If you are based in California, we encourage you to read this important information for California residents linked here.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
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