Vice President, Global Quality

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POST DATE 9/17/2016
END DATE 10/18/2016

Pfenex Inc. San Diego, CA

San Diego, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)



As a key member of the senior leadership team, the Vice President, Global Quality (VPGQ) is responsible for the overall quality functions for the corporation on a global basis. The executive formulates, prioritizes, executes and drives the GxP quality strategy to include, but not limited to, communicating the company's quality programs/vision to internal and external stakeholders; budgeting and resource planning; development and optimization of processes and procedures that meet global regulatory standards; training and development; participation of selection and oversight of quality contract service providers including CMOs and CROs; disposition of commercial products; serves as the primary technical liaison and subject-matter-expert (SME) to the organization as well as U.S. and international agencies for all areas related to quality control and quality assurance. The VPGQ will lead, develop and mentor team members to ensure a cohesive, dedicated and productive quality group.


As part of the leadership team, participates in the company's global strategy as relates to quality and quality initiatives
Develops and executes short- and long-term strategies and objectives for the quality function, refines and realigns as needed
Ensures world-class and tactical excellence of the quality programs including, but not limited to, department and company communications; document and quality systems; quality control (QC); quality assurance (QA); CAPAs; OOSs; change and document control; batch records; product labeling and specifications; quality standards and policies; audits and investigations; analytical test records and reports; disposition of all finished products; retention and workforce planning; regulatory compliance; and metrics/measurements/results
In partnership with senior management, human resources and hiring leaders, responsible for identifying current and future talent for the Company's overall strategic plan, ensuring it is in concert with the mission, values and culture of the organization
Leads, manages, develops and mentors quality team members to include indirect reports
Continually assesses the competitiveness of all quality programs and practices
Coordinates interactions with finance team to ensure programs have adequate budget and resources to support approved scope
Develops and ensures prompt implementation of initiatives, processes and projects with an emphasis of a performance-based culture focused on the company values
Ensures clear and definitive linkage between corporate strategy and operational activities
Identifies issues and facilitates problem solving, contingency planning, and escalates to primary stakeholders as needed
Key stakeholder of the electronic document management systems (EDMS); ongoing oversight after validation release
Makes recommendations to improve processes and procedures on an ongoing basis (continual improvement); executes or drives changes as required
Oversees and informs key stakeholders of all major QC & QA projects, issues and problems, and proposes solutions as appropriate and requested
Oversees GMP training sessions for internal employees across the globe
Oversees the planning, scheduling, conduct and reporting of internal and external audits (i.e., CMOs, CROs, analytical labs, etc.)
Oversight of contract service providers and related outsourced partners on a global basis as relates to quality standards
Oversight of partner audits and regulatory inspections serving as a quality escort, as needed
Prepares and delivers executive-level presentations for the quality function to key stakeholders as needed
Proactively takes initiative to identify, research and solve complex technical problems and issues; communicates status in a timely manner
Proposes and advances technical tools (e.g., Quality Systems) to ensure goals and objectives are met in the most efficient and metrics-driven way as possible
Remains current on global regulations, industry trends, current practices, new developments, and applicable laws regarding quality
Other duties as assigned or required