QA Manager

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 and onboarding experience.

PacBio is seeking an experienced QA Manager who is responsible for overseeing and building a Quality Assurance team. The QA team will work with our manufacturing departments in compliance to ISO9001 requirements for the San Diego site.

Responsibilities:

• Build, develop and lead a highly motivated Quality team. Establish and actively manage performance expectations, providing training and development work to achieve the company’s Quality initiatives to achieve the goals of the company’s manufacturing initiatives
• Setup and manage project improvements/standardization across the company by creating and continuously improving our Quality Management System
• Influence and build strong working relationships across PacBio organizations and departments and engage with business partners to define system gaps and future requirements for Quality Management Systems
• Drive the continuous improvement of the PacBio Quality Management System (QMS), including assuring effective management reviews, compliant handling (CRB), Doc Control/change control, Quality Review Board (QRB), QC infrastructure, internal auditing, R&D transfers, validation, and manufacturing support
• Ensure company-wide training is effective and that the site operates within the required quality guidelines
• Support regulatory strategies and policies for the successful eventual approval of all 510(k) or PMA submissions to the FDA, as well as worldwide, such as CE-IVD
• Support and influence the commercialization of New Product Introductions by working with the various PacBio Core Teams
• Ensure PacBio business practices and development strategies are compliant to applicable regulations
• Lead executive level quality management reviews
• Operate as a leader during compliance audits from FDA, ISO, Internal auditors, and customers
• Responsible for accomplishing results through the management of multiple PacBio teams as well as senior professionals
• Exercises control over resources, policy formulation and planning
• Develop and lead a Standard Operating Procedure team within PacBio
• Develop and maintain monthly metrics and reporting tools for all aspects of the QA function
• Schedule and conduct quality meetings
• Build and mentor team of quality associates
• 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.

Position Requirements:

• 5+ years of Quality industry and regulatory roles; Life science tools, medical device or instrumentation experience required
• Agile and SAP experience preferred
• Demonstrated experience working with external and commercial teams creating strategies that address customer needs, product compliance and specification
• Experience leading an in-house Quality Management System, required
• Excellent negotiation, interpersonal and communication skills
• Strong problem-solving, strategic-thinking, and critical analysis ability; able to make effective decisions and execute an appropriate course of action that complies with quality and regulatory requirements while supporting business objectives
• Establishes organizational standards. Leads and sponsors organizational, process improvement, and cross functional development
• Interprets, executes, and recommends modifications to organizational policies
• Ability to travel 10-20% time both domestically and internationally
• Ability to deliver strategic business insights in a dynamic environment
• Organized and detail oriented
• This is an on-site 5 days per week role
  

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.

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://careers@pacificbiosciences.com for assistance.

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