Overview
Quality Operations Manager/Sr Manager Jobs in Redwood City, California, USA at Corcept Therapeutics
The Quality Operations Manager/Sr. 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.
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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 suppliers, CTLs, and CMOs
Perform quality trends analysis and reports, recommending continual improvements opportunities
Preferred Skills, Qualifications and Technical *
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 ****
BS or MS 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 21
CFR
211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products
The pay range that the Company reasonably expects to pay for this headquarters-based position is $150,200 – $215,600; 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.
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Title: Quality Operations Manager/Sr Manager
Company: Corcept Therapeutics
Location: Redwood City, California, USA
Category: Quality Assurance – QA/QC, Pharmaceutical
