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Form of workThe Quality Operations Associate Director is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and disposition of pharmaceutical drug substance and drug product for commercial and clinical distribution. In addition, this role manages the Product Quality Complaint process and supports Drug Safety in regards to Pharmacovigilance activities (PV).
Responsibilities:
- Act as the Quality Assurance (QA) lead in providing oversight and support in various Chemistry, Manufacturing, and Controls (CMC) projects.
- Perform review of batch records and test data and perform product dispositions.
- Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations.
- Review and approval of validation protocols and reports (e.g., process, method, etc.).
- Lead and Author Annual Product Review (APR) effort by working cross-functionally with Regulatory and CMC to gather the necessary data and information.
- Work cross-functionally with the Drug Safety team to resolve quality events that can include product quality complaints, adverse event (ADE) reports, and deviations that can stem from the PV service provider, Pharmacy, and or internal team.
- Evaluate and approve Product Quality Complaints (PQC).
- Author and revise Standard Operating Procedures (SOPs) as needed.
- Generate, review, and negotiate Quality and Technical Agreements with Contract Service Providers (CSP).
- Lead and support Contract Service Provider (CSP) qualification audits that can include contract manufacturers, contract testing organizations, distribution depots, PV service provider, and pharmacy.
- Identify and lead areas of continuous improvement pertaining to Quality Assurance.
- 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.
- Provide cross training development opportunities; mentor and coach junior QA team members
Preferred Skills, Qualifications and Technical Proficiencies:
- 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 disposition of pharmaceutical products.
- 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 solid problem analysis and decision-making ability.
- Ability to lead or 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 required
Preferred Education and Experience:
- Bachelors or Masters degree in a 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.
- 12+ years' experience in bio/pharmaceutical industry including 7+ years in Quality Assurance.
The pay range that the Company reasonably expects to pay for this headquarters-based position is $175,000 - $207,000; 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.
If you are based in California, we encourage you to read this important information for California residents linked here.
