GCP Quality Lead
- San Francisco, CA
GCP Quality Lead
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry, by making clinical-grade genetic information affordable and accessible to guide health decisions across all stages of life.
Our team is expanding rapidly and we’re looking for people who are passionate about helping improve healthcare to join us.
Invitae is a rapidly growing, technology-driven genetics testing company. Our mission is to empower doctors and patients to use genetic & genomic information to make informed medical decisions at all life stages. We are seeking an experienced Clinical Quality Assurance Lead who has understanding of companion diagnostics to join our team. The candidate must have experience with Good Clinical Practice or Good Laboratory Practice experience working in the biopharmaceutical industry.
What you will do:
- Build the GCP QA capability designed to serve as counsel and QA support for our clinical partnerships while maintaining a strong independent role for QA decision-making.
- Assist in developing, implementing, and communicating the GCP QA vision, goals, core capabilities, and value while championing a strong Quality Culture.
- Proactively assess compliance issues and risks, providing strong leadership and expertise in maintaining GCP compliance standards.
- Serve as the expert GCP consultant for issue management & issue escalation, with a focus on critical and major quality events. Communicate critical risks to senior leadership, requiring diplomatic and objective representation of the issue(s).
- Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Study Source Data Audits, Trial Master File audits, Database audits, Clinical Study Report audits).
- Review deviations, investigations, and change control documentation; and assess acceptability of the content and documentation.
- Maintain QA files and QA audit reports.
- Interact with internal and external clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Perform other functions as assigned by Quality Assurance Management.
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect Quality Issues and the need for CAPAs and assist Quality Assurance Management with the QI/CAPA process
Who you are:
- Bachelor’s degree in science or related field
- Minimum of 4 years of experience in biopharmaceutical industry quality that includes clinical, laboratory and or manufacturing functional operations. GCP experience required, GLP and GMP desired.
- Working knowledge of applicable Clinical, Data Management and External Site Services function regulations and guidances (GCP/GLP/cGMP/GDP E-records & E-signatures) regulations and related guidelines
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
By joining Invitae, you’ll work alongside some of the world’s experts in genetics and healthcare at the forefront of genetic medicine. We’ve created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization.
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
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