Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
Perform review of executed batch records and test data and perform product disposition
Review and approval of validation protocols and reports (e.g., process, method, etc.)
Lead and support quality audit of contract service providers
Develop, review, and revise Standard Operating Procedures (SOPs) to reflect current industry best practices and regulatory standards
Generate and review Quality and Technical Agreements with Contract Service Providers (CSP)
Perform quality trends analysis and reports, recommending continual improvements opportunities
Support the management and growth of the Quality Assurance Operations team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team's capabilities meet Corcept's future needs
Support the QP/RP to ensure timely disposition of batches
Provide cross training development opportunities, mentor and coach junior QA team members
Preferred Skills, Qualifications and Technical Proficiencies:
Strong QMS experience in the EU and knowledge of EU country specific requirements
Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products
Ability to work independently and communicate effectively with project team members and management groups and suppliers
Work well in a project team environment with solid problem analysis and decision-making ability
Ability to lead or support internal and external compliance audits of suppliers, CTLs, and CMOs
Ability to work independently in addition to clearly and concisely communicate both in writing and verbally
Ability to identify compliance risk and recommend mitigations
Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
Strong statistical mindset and metric presentation
Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
Travel required
Preferred Education and Experience:
Bachelor's or master's degree in science, engineering or related field
At least 10 years in the bio/pharmaceutical industry
At least 5-10 years in Quality Assurance
Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products
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Benefits
Paid time offRemote work options
Additional Information
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com .
The Quality Assurance Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance with the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution. This role will also be responsible for the oversight of 3PLs and work closely with the QPs to distribute products in EU. This is a remote role.
Corcepttherapeutics · Amsterdam, Netherlands