Quality Assurance Operations Manager

Corcept TherapeuticsAmsterdam, North Holland, Netherlands

Remote Full-time

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Experience Level

Manager

Qualifications

Responsibilities:Serve as the Quality lead and provide support for various Chemistry, Manufacturing, and Controls (CMC) projects. Collaborate across departments with the CMC team to oversee and address quality investigations arising at contract manufacturing and testing organizations. Conduct reviews of executed batch records and test data, as well as determine product disposition. Review and approve validation protocols and reports, including process and method validations. Lead and facilitate quality audits of contract service providers. Develop, review, and update Standard Operating Procedures (SOPs) to align with current industry best practices and regulatory standards. Create and review Quality and Technical Agreements with Contract Service Providers (CSP). Conduct quality trend analyses and reports, recommending continuous improvement opportunities. Support the management and development of the Quality Assurance Operations team to attract and nurture talent.

About the job

For over 25 years, Corcept Therapeutics has dedicated itself to understanding cortisol, a potent hormone that can contribute to a variety of diseases when left unchecked.

Our robust portfolio includes innovative therapies for hypercortisolism and oncology. With over 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists, we are advancing clinical trials for patients suffering from hypercortisolism, solid tumors, ALS, and liver disease. Corcept is committed to harnessing cortisol modulation to tackle some of the most challenging health issues faced by patients today.

Headquartered in Redwood City, California, we invite you to learn more about our mission at www.corcept.com.

The Quality Assurance Operations Manager plays a pivotal role in overseeing various operational activities that ensure product quality and compliance in the manufacture, testing, control, validation, and release of pharmaceutical products for both commercial and clinical distribution. This position involves managing third-party logistics (3PLs) and closely collaborating with Qualified Persons (QPs) to facilitate product distribution throughout the EU. This is a remote position.

About Corcept Therapeutics

Corcept Therapeutics is a pioneering biopharmaceutical company that specializes in the science of cortisol modulation. With a rich history of over 25 years, we are at the forefront of developing treatments that address severe health conditions linked to cortisol dysregulation. Our advanced research and clinical initiatives empower us to make significant strides in the fields of oncology and endocrinology.

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