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Associate Director, Quality Systems - Menlo Park, CA, United States - Corcept Therapeutics
Description
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR).
In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases.
With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advance the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
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 operationsAchieve quality and GxP objectives while effectively balancing competing priorities and potential compliance risks with ongoing projectsSupport cross functional partnerships by delivering phase appropriate solutions for Corcept's quality management systemRecognize and assess opportunities that promote QA's ability to deliver innovative solutions that support Corcept's growth and evolving business needsWork with SMEs to develop controls and set management standards for system environments, while managing vendor relationships and licenses in line with Corcept's growthSupport Inspection Readiness objectives by identifying risks and implementing fixes or developing risk strategiesMentor the Quality Systems team with development opportunities and ensuring the team's capabilities meet Corcept's future needsImplement improvements to GXP Standard Operation Procedures (SOPs)
Support regulatory authority inspections, including by coordinating cross-functional partners, in inspection preparation, hosting and responding to observationsPreferred Skills, Qualifications and Technical Proficiencies:
Experienced and well versed in System Development Lifecycle (SDLC)
Working knowledge of Veeva Quality Suite, LMS systemsHands on configuration experienceDirect involvement and experience with regulatory inspections and auditsLarge system implementations leading cross-functional groupsAcumen and comfort in persuading and influencing others at various levels of the organizationVendor evaluation and selection processKnowledge of principles for software validation and GAMP 5Excellent meeting facilitation and skillsExcellent written and oral communication skillsPreferred Education and Experience:
BA/BS in a scientific disciplineStrong 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 roleExperience in working with enterprise systemsThe 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.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
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 EmployerCorcept 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.
