Supplier Quality Manager at Invitae (Formerly ArcherDx)
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 genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.Responsibilities:
Job performance will involve a variety of activities (multiple as defined in the QMS) including:
- Maintain compliance with all company policies, quality systems, procedures, per ISO 13485:2016, 21 CFR 820 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 in the context of Supplier Quality Management
- Lead supplier monitoring per the QMS SOPs to ensure suppliers meet product quality requirements
- Lead supplier development activities for continuous improvement of supplier performance prioritizing critical suppliers from a product and supplier perspective
- Develop and lead supplier audit schedule, prioritized by risk
- Implement quality agreements with suppliers
- Perform and/or arrange for performance of supplier audits based on risk
- Handle supplier corrective action reports and associated continuous improvements
- Manage supplier change management per QMS SOP
- Monitor and report supplier performance per QMS SOP, identifying trends and opportunities for continuous improvements at the supplier as well as from an Invitae design or manufacturing perspective
- Act as a subject matter authority for the SQMP in customer and regulatory audits.
- Liase with larger Invitae supplier quality organization to drive commonalities where appropriate
- Handle the document archiving and retrieving process for supplier quality records
- Work with cross-functional teams in problem-solving
- Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
- Safeguarding the privacy and security of protected health information and European Union personal data.
- Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
- 8+ years of experience in a regulated industry with a minimum of 3 in Supplier Quality Management
- Bachelor’s Degree (science discipline preferred); or equivalent experience
- Ability to travel up to 20%
- Previous audit experience preferred
- Attention to detail
- Ability to interact with multiple fields, and communicate clearly and effectively verbally and in writing.
- Ability to use good problem-solving skills.
- Excellent planning and organization skills.
- Effective analytical skills.
- Ability to work in a fast-paced and dynamic environment
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to coordinate, prioritize, and delegate tasks to efficiently move projects forward.
In Colorado, our competitive compensation package includes a base salary starting from $133,500 per year. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
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.