PacBio is seeking an experienced and driven QA Manager who will be responsible for implementing and maintaining effective quality system processes and a dedicated QA team for our San Diego site. 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 an on-site role.
- Lead local implementation of a corporate ISO 9001 and ISO 13485 Quality Management System that meets business and customer expectations.
- Communicate quality-related principles and applicable compliance requirements to the management team and greater organization. This includes authoring procedures and leading training as needed.
- Promote use of risk-based approaches, use of sound investigation and corrective action methods. Approve CAPA risk assessments, corrections, containment and communication in response to identified performance issues.
- Develop and lead a highly motivated Quality Assurance team. Establish and actively manage expectations, provide training and mentoring to drive professional development.
- 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.
- Represent QARA function on design, development and product improvement project teams. Provide guidance and approval on technical documentation such as validations, risk analyses, investigations, changes, etc.
- Partner with Supply Chain on supplier quality management program activities.
- Serve as an extended QMS Management Representative ensuring quality system effectiveness in meeting customer and any applicable regulatory requirements.
- Manage ongoing collection, analysis and presentation of QMS performance data.
- Serve as QARA contact and host with auditing bodies (external registrars, customers and internal corporate team members).
- Other duties as required.
- 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.
- 5+ years of relevant quality systems experience with supervisory responsibility.
- Excellent communication, presentation, risk-based decision making and negotiation skills.
- Experience implementing ISO 9001 and 13485 QMS processes.
- 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.
- Experience working in both a biotechnology / life science and regulated environment strongly preferred.
- ISO Lead Auditor, Quality Engineer, Quality Manager, Six Sigma Certification 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.
- This is an on-site, 5 days per week role.
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://firstname.lastname@example.org for assistance.
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