Bayer Director Quality Systems and Compliance in Berkeley, California
Your tasks and responsibilities
Provides strategic leadership, direction, and oversight for GMP Systems and Compliance with decision making to the Bayer Berkeley site to reduce the risk of regulatory action Accountable for Supply Center training and internal audit program, document control and archiving, and risk management. Leads the Quality Management Review (QMR) program at the site level and provides CMS system administration.
More specifically related to this role, the incumbent will have responsibilities to include, but not limited to: 1. Responsible for engaging strong intradepartmental and cross-functional/ organizational relationships to drive compliance to Quality Systems, including investigation and approval of compliance related deviations 2. Oversees Product and System Metrics coordination and presentation, including APR to ensure that the Quality Systems and Process remain in a continuous state of control 3. Prepares site for regulatory inspections, provides front room and back room support and is responsible for generating response documentation. The incumbent is also responsible for responding to agency questions and overseeing TRD revision process. 4. Responsible for company’s Compliance Program to ensure compliance with regulatory and auditing agencies and all applicable standards worldwide. Function as the primary contact with FDA, EMA and international regulatory authorities. Provide counsel, training and interpretation of FDA and other regulatory requirements to all company personnel. Accountable for internal audit/self-assessment program, Compliance Management System (CMS) administration and Site Master File. 5. Direct sites risk management team. Responsible for identifying potential risks, providing risk facilitation, being proactive in identifying solutions to mitigate the risks and work effectively with team members and senior management to resolve them. 6. Responsible setting the strategy and direction for the Technical Training team, including management of the LMS (Learning Management System), new hire onboarding and annual GMP training. 7. Oversees document control and archiving processes. 8. Provide effective leadership including: development and implementing objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; assisting with Performance Calibration/Talent Pool Management/Succession Planning; individual goal setting/performance reviews; training and development; supporting workforce diversity, quality and safety and supporting supervisors/managers in management of their employees/department which support achievement of individual/department/business objectives
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. Related to this position, we are seeking an incumbent who possess the following: Qualifications: BS, Science; MS preferred 15+ years of GMP experience; experience in a compliance role a must (i.e., self-inspection, regulatory audit support, risk management). Knowledge of multicounty regulations (e.g., US, EMA, Australia, Japan, etc) Focus is internal and external. Interacts with subordinates, peers and Senior Management. Provides effective leadership to employees. Proactively develops positive employee relations climate. May coach, counsel, manage and direct personnel in assignments relative to changing priorities, sense of urgency and utilization of multiple skills sets.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled