Manager, Quality Assurance Compliance

About the position Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. 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 Manager, Quality Assurance Compliance role ensures compliance with GxP guidelines across all supplier and vendor management relationships. This role is responsible for supplier quality activities, ensuring quality standards are met, managing supplier audits, and partnering with internal and external stakeholders to drive continuous improvement. This role is also responsible for negotiating, drafting and management of Quality Agreements and maintaining/tracking key compliance metrics for internal, external adherence. This position requires close cooperation with the QA Operations team members (Commercial and Clinical QA) and CMC team members. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities

• Support the qualification, monitoring and requalification process, including risk assessments of suppliers
• May participate in GxP vendor qualification through risk-based audits and performance criteria
• Support improvement initiatives to enhance supplier selection and compliance
• Maintain and tracks key compliance metrics during management reviews to help ensure internal and external adherence to quality compliance and/or improvement opportunities
• Manage the audit lifecycle such as scheduling, planning, issuing agendas, issuing reports, evaluating responses, requesting clarification, issuing Corrective Action (CA), Preventive Action (PA) and closing audits in Veeva
• Develops external audit schedule for QA Ops
• Ensure all suppliers comply with Corcept’s expectation, internal procedures and regulatory requirements. (FDA, EMA, and other international health authorities)
• Authors Supplier Quality Agreements and work with internal and external stakeholders in the review and approval of quality agreements
• Authors SOP in support of continual improvement initiatives

Requirements

• Knowledge of pharmaceutical manufacturing technologies and processes
• Ability to work independently and communicate effectively and concisely (both verbal and written) with project team members and management groups and CSPs
• Work well in a project team environment with problem analysis and decision-making ability
• Ability to support internal and external compliance audits of suppliers, CLOs, and CMOs
• Ability to work independently in addition to clearly and concisely communicate both in writing and verbal
• 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 pragmatic decision making
• Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
• Travel may be required
• Bachelor’s or master’s degree in chemistry, biology, engineering or related field
• Thorough knowledge of 21 CFR 210/211 global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products
• 6+ years’ experience in bio/pharmaceutical industry including 3+ years in Quality Assurance
• Applicants must be currently authorized to work in the United States on a full-time basis.

Nice-to-haves

• Strong Veeva QMS experience is preferred

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