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Senior Manager Quality Systems Validation


This is a Full-time position in Bothell, WA posted March 7, 2021.

nnThe Senior Manager of Quality Systems Validation works with internal and external stakeholders to ensure GMP computer systems and equipment are validated and maintained in a state of compliance.

The role is responsible for ensuring that applicable systems and equipment meet Seagen internal standards, regulatory requirements, and applicable guidances.

Through the management and leadership of the Quality Systems Validation group the individual will ensure a quality focused culture is instilled in the organizations responsible for GMP computer systems and equipment.

The position will lead a group of QA validation professionals in charge of the validation lifecycle of GMP computer system applications and equipment.

Leads the Quality Information Systems support team providing technical administrative support for electronic systems supporting GMP activities.nn nnThis individual will represent Quality Systems Validation in cross functional teams ensuring compliant policies, procedures, systems and practices are implemented, maintained and routinely assessed to applicable regulations.

The individual will play a key role in advancing the Quality Systems function in support of GMP compliance in a global biopharmaceutical company.nn nnPrincipal Responsibilities:nn nnLeads the Quality Systems Validation group ensuring activities supporting the validation lifecycle for GMP computer systems and equipment are compliant and performed to Seagen proceduresProvides guidance and oversight to ensure that validation, implementation and change management of GMP electronic systems and equipment is performed in accordance with Seagen policies and procedures, applicable regulations, and industry guidancesLeads the Quality Information Systems support function ensuring adequate resources and skills are available to provide technical administrative support for users of electronic quality systems, including troubleshooting and implementation of corrective actions, performance of periodic reviews, and maintenance of systems in a compliant mannerEngage with business groups such as Quality Control, Facilities, Manufacturing, IT, and user groups to foster collaboration, ensure cooperation, and positively influence outcomesWorking with customer and support groups to strategically align and scale resources to ensure an efficient and flexible operation to meet demandsLead and influence cross-functional teams to support Seagen and Quality Systems initiativesWrite, revise, and approve applicable cross-functional policies, procedures and standards based on applicable regulatory requirements, guidances, and industry best practicesSponsor and champion continuous improvement activities within the Quality Systems group using Lean principlesRepresent the Quality Systems Validation group on cross functional teams to establish, maintain, and improve validation standards in accordance with regulatory requirements, guidances, and industry common practices using risk based and scientific principlesProvide regulatory inspection supportRepresent Quality Systems Validation during regulatory inspections and third party or partner auditsDevelop and oversee the establishment, maintenance, and trending of leading and lagging metrics related to area of responsibilityParticipates in the creation, review, and approval of change controls, deviations, CAPA, and systems periodic reviews related to area of responsibilityLeads the hiring, mentoring and development of staffParticipate in the development of strategy and goals for department and staffLeads the Quality Information Systems support teamnn nnRequired Qualifications:nn nnRequires a minimum of 14+ years’ experience in pharmaceuticals or biopharmaceuticals, and at least 3 years of experience in people managementDemonstrated ability to work cross-functionally and to develop and maintain strong business partner relationshipsWorking knowledge of cGMP is required, including ability to understand and apply regulations, guidances and industry best practices to area of responsibilityExperience with the validation of electronic systems and equipment within the pharmaceutical or biopharmaceutical industryDetail oriented with strong organizational, time, and project management skillsStrong written and verbal communication skillsnn nnPreferred Qualifications:nn nnA minimum of a bachelor’s degreenn

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