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Operations Manager
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Operations Manager
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Manager Clinical Operations
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Operations Manager
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Business Operations Manager
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Restaurant Operations Manager
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Business Operations Manager
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Business Operations Manager
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Program Operations Manager
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Quality Operations Manager
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Operations Manager
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Operations Manager
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Manager, Accounting and Business Operations
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Operations Manager
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Quality Operations Manager - Menlo Park, 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's 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 advancing 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.
The Quality Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution.
Responsibilities:
Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projectsWork cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizationsPerform review of executed batch records and test data, and perform product dispositionsReview and approval of validation protocols and reports (e.g., process, method, etc.)
Lead and support quality audit of suppliers, CLOs, and CMOsPerform quality trends analysis and reports, recommending continual improvements opportunitiesPreferred Skills, Qualifications and Technical Proficiencies:
Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processesStrong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical productsAbility to work independently and communicate effectively with project team members and management groups and suppliersWork well in a project team environment with solid problem analysis and decision-making abilityAbility to lead or support internal and external compliance audits of suppliers, CLOs, and CMOsAbility to work independently in addition to clearly and concisely communicate both in writing and verbalAbility to identify compliance risk and recommend mitigationsAbility to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulationsStrong statistical mindset and metric presentationProficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and VisioTravel requiredPreferred Education and Experience:BS or Master's degree in science, engineering or related field10 years in the bio/pharmaceutical industry5-7 years in Quality AssuranceKnowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical productsThe pay range that the Company reasonably expects to pay for this headquarters-based position is $150,000 - $176,000; 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:
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.