PacBio is seeking an experienced and driven Quality Systems & Regulatory leader who will be responsible for implementing and maintaining quality system processes for our US-based PacBio sites. This individual will function in a key leadership role for the company and must demonstrate excellent communication, risk-based critical thinking, and negotiation skills. This role is expected to collaborate closely with all matrix functions in support of delivering innovative and high-quality solutions that enable the promise of genomics to better human health. This is a hybrid role based from Menlo Park headquarters.
- Develop and execute a Quality Systems and Regulatory roadmap that supports execution of corporate strategy to bring both Research Use Only (RUO) and In Vitro Diagnostic (IVD) products to a global market.
- Establish regulatory pathways and strategies for growth in clinical markets. Collaborate with customers, suppliers and SMEs to build technical documentation required for regulatory submissions worldwide.
- Oversee both product safety and QMS compliance certifications and enforce standard policy across multiple sites and functions. Serve as primary QARA contact with auditing bodies (external registrars, regulatory agencies, customers and internal corporate team members).
- Develop and lead a highly motivated team who drives change, improves effectiveness of our QMS and ensures product safety & compliance. Establish and actively manage expectations, provide training and mentoring to drive professional development.
- Communicate quality-related principles and applicable compliance requirements to the executive leadership team, members of the Board and greater organization. This includes authoring procedures, leading training, presenting to all levels of the organization and monitoring implementation effectiveness.
- Support evaluation and completion of customer initiated regulatory surveys and associated requested technical and quality system documentation.
- Promote use of risk-based approaches, use of sound investigation and corrective action methods. Author and approve CAPA risk assessments, corrections, containment and communication in response to identified performance issues.
- Influence and build strong working relationships across PacBio matrix functions to achieve corporate-level business and quality objectives.
- Drive continuous improvement through strategic quality planning processes.
- Other duties as required.
- A minimum of 11 years of quality and regulatory experience in the Life Sciences, Medical Device or IVD industries with 5+ years of managerial experience. Total professional experience may be less for candidates with a Master’s or PhD degree.
- Experience implementing ISO 9001, 13485, 14971, IVDR and MDSAP QMS processes.
- Working knowledge of IEC/EN 61010, EN 61000, IEC 60825, EN 61326, IEC 62304, IEC 62366.
- Experience working in both a biotechnology / life science and regulated environment strongly preferred.
- Excellent communication, presentation, risk-based decision making and negotiation skills.
- Strong problem solving, strategic thinking, and critical analysis skills; ability to execute an appropriate course of action that complies with quality and regulatory requirements while supporting business objectives.
- Customer-centric focus.
- ISO Lead Auditor, RAC, Quality Engineer, Quality Manager, Six Sigma Certifications desirable.
- Experience working in and administering QMS tools such as Oracle Agile PLM, ComplianceWire and SAP ERP is also desired.
- Ability to travel 10-20% time both domestically and internationally.
You may be required from time to time to visit and work at PacBio locations and for such times as the Company considers necessary for the proper performance of your duties.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
$191,300.00 - $258,800.00
Please be aware that, as a condition of employment, proof of COVID vaccination is required for all U.S.-based employees (subject to limited exceptions).
To ensure the health and safety of all PacBio employees and our prospective candidates, we have instituted a virtual interview experience.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at PacBio. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. PacBio does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, PacBio employees or any other company location. PacBio is not responsible for any fees related to unsolicited resumes/applications.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact us at 650-521-8000, or http://email@example.com for assistance.
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