Quality Assurance Operations Manager - Remote

About the Role

We are seeking a Quality Assurance Operations Manager to join our team at Corcept Therapeutics. This remote position offers an exciting opportunity to lead quality assurance operations in the biotechnology research sector, specifically focusing on cortisol modulators. You will play a crucial role in ensuring product quality and compliance in the manufacture, testing, control, validation, and release of pharmaceutical products.

What You'll Do

• Act as the Quality lead and support various Chemistry, Manufacturing, and Controls (CMC) projects.
• Collaborate cross-functionally with the CMC group to oversee and resolve quality investigations at contract manufacturing and testing organizations.
• Review executed batch records and test data, performing product disposition.
• Review and approve validation protocols and reports, ensuring compliance with regulatory standards.
• Lead and support quality audits of contract service providers.
• Develop, review, and revise Standard Operating Procedures (SOPs) to reflect current industry best practices.
• Generate and review Quality and Technical Agreements with Contract Service Providers (CSP).
• Perform quality trends analysis and reports, recommending continual improvement opportunities.
• Support the management and growth of the Quality Assurance Operations team, fostering a rewarding professional environment.
• Provide cross-training development opportunities and mentor junior QA team members.

Requirements

• Bachelor’s or master’s degree in science, engineering, or a related field.
• At least 10 years of experience in the bio/pharmaceutical industry.
• A minimum of 5-10 years in Quality Assurance.
• Strong QMS experience in the EU and knowledge of EU country-specific requirements.
• Proficient in analytical chemistry and pharmaceutical manufacturing technologies.
• Ability to work independently and communicate effectively with project teams and management.
• Experience leading internal and external compliance audits.
• Strong statistical mindset and proficiency in Microsoft Office tools.

Nice to Have

• Experience with 21CFR211, global cGMP regulations, and ICH guidelines.
• Experience in a remote work environment.

What We Offer

• Competitive salary ranging from $120,000 to $150,000 per year.
• Comprehensive health benefits and a supportive work environment.
• Opportunities for professional development and career growth.
• Flexible remote work arrangements.
• A chance to contribute to groundbreaking research in the biotechnology field.