Bayer Sr. Manager, Final Product Manufacturing Conformance in Berkeley, California
Your tasks and responsibilities
Purpose: Provide management oversight of all Discrepancy Investigation activities within the Production Process Area. Partners with Global and Local Quality Units to insure and improve Compliance to Quality in the Production and Discrepancy Investigation Units.
•Initiate interaction with Global and Local Quality Units to insure and improve Compliance to Quality in the Production Unit and the Discrepancy Investigation Unit. Understand and challenge industry guidance towards improving operational efficiency and compliance. Liaison between both local and global quality to resolve Critical Deviations in the production process. Reduce DR generation in the Process Area and ensure that adverse trends are addressed quickly and effectively. •Function as Key Contact for Discrepancy Management during Regulatory Agency Inspections. Required to escort Inspectors and explain Major/Critical Deviations as well as process steps. •Lead Critical Discrepancy Investigations to closure according to Directives and Procedures, up to and including PQSC (Product Quality Steering Committee) review. •Determine root cause for Write-Offs and Scrap, and implement effective corrective actions to eliminate recurrence. •Ensure that an appropriate training program is in place and is implemented. •Manage cost center by reviewing monthly spending and taking necessary action to control and refine the operating budget. Propose a capital investment plan for the Process Unit to maintain cGMP compliance of facilities and equipment. •Ensure compliant and efficient use of Production Systems, e.g. SAP, MES, SCADA and Dev@Com. •Support and achieve FC release process cycle time targets by providing leadership and guidance to the Final Container Release Team and Discrepancy closure efforts. •Participate in the technical process review and approve all new or modified products to be manufactured within the Process Area before submitting for Regulatory Agency approval and/or release to the market.
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Required Qualifications: •BS/MS/PhD in Business, Technology or Medicine, plus relevant experience in Technology, a background in Chemical, Industrial, Electrical, or Mechanical Engineering is preferred.
•BS 10+ years •MS 8+ years •PhD 4-6+ years or an equivalent combination of education and experience •Ability to think and act strategically •Knowledge of Fish Born, 5 whys, KT and other Root Cause Analysis methods •Knowledge of budgeting and expense control •Ability to shift priorities and effectively perform under pressure •Demonstrated strong leadership capabilities •Ability to operate within a team atmosphere •Must be skilled at leading an organization through a culture change •Willingness to take strong positions, even if they are not popular •Demonstrate mature judgment and integrity of confidential employee information •Detailed knowledge and experience of Aseptic Filling, Capping, Inspection and Packaging Processes •Ability to guide a Discrepancy Investigation staff through a range of process issues
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/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.