Senior Manager, Quality Systems Change Control at Boehringer Ingelheim Fremont, Inc. in Fremont, California
Job Duties: Serve as a site subject matter expert for quality change management. Provide continuous technical support, expertise, and guidance to all functional areas (production, engineering, regulatory, etc) to plan, review, approve and implement changes in the GMP environment in compliance with GXP and other related regulations. Communicate issues, project updates, and project proposals to BI internal stakeholders and site management. Manage change control workflows including the implementation, training, and ongoing development of workflows for the site. Develop and manage procedures for quality systems to support changes and process improvements in compliance with regulatory requirements. Support preparation of regulatory documents related to changes implemented in the GMP environment and to quality systems. Maintain and update company procedures for quality systems in response to changes in regulations or standards. Provide training, creation and maintenance of user accounts in sap. Identify opportunities for and lead continuous improvement projects in all functional areas (production, engineering, quality control, etc) related to change management. Provides oversight and approvals for deviations, CAPAS and change controls to ensure activities are conducted in bi procedures and regulatory requirements. Work closely with global quality systems owners and represent site at network meetings. Determine yearly goals for the team aligning with company’s goal provided by site management and create action plan to achieve these goals. Establish change control review board and ensure change controls are assessed by required functions and executed per plan and timeline. Facilitate following meetings: weekly change review board and change control clinics. Identify and develop critical metrics for quality systems. Create presentations and report metrics at site management meetings. Participate and support internal and external audits for GMP compliance. Responsible for presenting quality change management process at internal audits, client audits and health authority inspections. Support and prepare responses and/or provide additional information related to quality systems as requested by regulatory agencies. Responsible for presenting quality change management process at internal audits, client audits and health authority inspections. Prepare and review responses and/or provide additional information related to quality systems as requested by regulatory agencies. Support inspection readiness activities as a member of inspection readiness team at the site. Establish and maintain a quality change management system for all departments at the site in compliance with regulatory requirements. Represent quality systems at inspection readiness meetings.
Job Requirements: Bachelor’s degree (U.S. or foreign equivalent) in Microbiology, Biology, Chemistry, Biotechnology, Biopharmaceuticals or related field and six (6) years of experience in job offered or in a related role OR Master’s degree (U.S. or foreign equivalent) Microbiology, Biology, Chemistry, Biotechnology, Biopharmaceuticals or related field and four (4) years of experience in job offered or in a related role. Must have one (1) year of experience leading quality, manufacturing or related areas in accordance with CGMP principles. Must have experience with: GMP biotechnology manufacturing and biopharmaceutical development processes; CGMP regulatory compliance standards and regulatory filings; validation of biopharmaceutical facilities, equipment and process; and quality management systems and related regulatory guidelines.
Work Schedule: 40 hours per week (8:00am to 5:00pm)