Supplier Quality and Internal Audit Leader
- San Francisco, CA
Office location – San Francisco, California
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 reinventing genetic testing by making it more affordable and accessible than ever before.
What you will do:
The Quality Systems and Internal Audit Leader is responsible for two key functions
- Supplier Quality oversight, ensuring the consistency of approach to the management of suppliers, and for ensuring that they meet the quality expectations of Invitae. This role will partner closely with Supply Chain, Operations and Quality Systems to manage supplier quality and provide leadership with critical vendor lists, supplier quality assessments, supplier quality investigations and supplier quality metrics.
- Internal Audit management, ensuring that we adhere to the principles of good auditing practices and provide objective assessments of the health of our Quality Systems throughout the network of Invitae Clinical Laboratories.
Additional responsibilities will include projects as they relate to supplier quality, internal audits and active participation in quality systems continuous improvement. This position reports to the QualitySystems Leader, with strong ties to internal customers.
Core Job Responsibilities:
- Support the fulfilment of supplier quality and internal audit requirements in accordance with Invitae QMS (ISO 15189 and ISO13485)
- Coordinate supplier quality requirements for Invitae Design Control and Change Control programs.
- Proactive monitoring of the performance of suppliers to ensure compliance with requirements, quality processes and continuous improvement plans.
- Conduct investigations pertaining to supplier quality to ensure appropriate corrective and preventive actions.
- Manage schedule and conduct internal audits of our clinical laboratory operations in adherence to Invitae protocol.
- All other duties assigned by Quality Systems Leader.
Who you are:
Education and Experience Qualifications:
- Bachelor’s degree in a scientific discipline required (including engineering).
- 5+ years quality experience in LDT, Bioprocess, Pharma or medical device (IVD) manufacturing.
- ASQ certified quality engineer (i.e. CQE or equivalence) preferred
- Advanced knowledge of 21 CFR 820, ISO 13485, cGMP, GXP and good documentation practices
- Expert level use of Word, Excel, and PowerPoint and experience with document management systems
- Advanced analytical and problem-solving skills.
- Strong interpersonal, planning, and organization skills
- Proven team spirit and cross-functional collaboration
- Excellent oral and written communication skills
- Must be able to work independently and within matrixed environment.
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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