Quality Manager | GenomeWeb

Quality Manager

Organization
Becton Dickinson
Job Location
Menlo Park, CA
Benefits

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Job Description

Reporting to the Director of Quality, or a Senior Manager, the Quality Manager provides direct management to technical and managerial staff. The role determines the tactics required to achieve departmental and plant/business objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; manager ensures product safety, product quality and compliance with all relevant global regulations and customer expectations.

Success is measured in terms of the frequency and scale of product quality and organizational issues. Through stakeholder engagement; and people development; the Manager produces durable and industry leading results supporting key business drivers.

• Engages with quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision.
• Proactively identify and work through obstacles that may hinder associates from focusing on and delivering their individual impact goals. Fulfill obligations in order to comply with applicable regulations and procedures.
• Function as the technical Quality leader within the competencies managed by the plant/business
• Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions.
• Continuously evaluate departments/plants/business progress toward tactical goals and objectives adapting them to meet customer and business needs
• Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by department/plant/business goals.
• Develop and implement best quality practices.
• Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the product quality, the company and its standards.
• Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.
• Pursue and maintain a functional knowledge of global regulation affecting the local business.
• Contributes to the attainment of budget goals by managing department spends, may manage a formal budget
• Manages, occasionally through subordinates supervisors, the coordination of the activities with responsibility for results, including costs, methods, and talent management.


Requirements

• Minimum Bachelor’s degree in science, engineering or other relevant discipline, with a minimum of five years relevant technical experience including three years of direct supervision and setting up a quality system.

• Minimum Bachelor’s degree in science, engineering or other relevant discipline, with a minimum of five years relevant technical experience including three years of direct supervision and setting up a quality system.

Knowledge and Skills:
• Design, develop and implement the quality management systems for the Genomics business unit and required quality system level (RUO/ IVD and/or Medical Device).
• Develop Genomics level as well as site specific procedures to support R&D and manufacturing operations at the US site and coordinate/support/collaborate with the Quality group in and Ireland to ensure one Quality system for all of BD Genomics.
• Manage worldwide Genomics quality personnel.
• Support the growth of the Genomics business unit world wide
• Quality leadership experience in development and production industry including expertise in ISO 9001, ISO 13485 and 21 CFR Part 820.
• Excellent communication and interpersonal skills enabling effective cross functional, cross site, multinational teamwork
• Responsible for daily quality engineering, quality assurance and final product release for Cellular Research products being manufactured in Menlo Park site.
• Ability to work under pressure and to tight deadlines
• Experience dealing with regulatory authorities
• Auditor training and/or experience is an advantage for this position
• LEAN/ Six Sigma certification preferred

 

About Our Organization

Cellular Research, Inc., a biotechnology research and development company founded in 2011 by innovators from Silicon Valley and Stanford University, was recently acquired by Becton Dickinson and has become an integral part of the new start-up Genomics business at BD.

Our mission is to revolutionize life science research by enabling high-resolution investigation of single cells and limited samples, thereby creating new benchmarks and delivering new capabilities in discovery and drug development. Cellular Research has developed Molecular Indexing to deliver these capabilities. Molecular Indexing is a revolutionary technology that enables direct and precise counting of individual molecules, genes, chromosomes, and other genetic materials in very small samples and individual cells.

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