Lead and manage plant quality functions, ensuring compliance with regulatory requirements and internal policies. This role supports development and execution of quality plans, process improvements, and audit management. Responsibilities Support development and maintenance of the plant strategic quality and compliance plans and policies. Accountable for the effective execution of processes carried out under departmental leaders (Quality Engineering, Quality Assurance, Quality Control), by prioritizing and managing people, resources, and budget to accomplish expected requirements and performance. Engage and provide leadership directions/objectives, coaching and personal development of site’s Quality associates to perform to their best ability and meet both personal and plant objectives. Define framework for department objectives, operation schedule, processes, and budgets. Act as the plant “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution. Build an influential and effective network and communication with WW Quality and Regulatory functions, other plant Quality Leaders and key WW functions (R&D, Design Assurance, Post Market Surveillance, Engineering, Supply Chain, WW Operations and Manufacturing, etc.) to ensure alignment around global and local priorities. Build an influential and effective network and communication with plant leadership team members in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement. Accountable to successfully manage and communicate quality issues. Identify quality improvement opportunities within operations and partner with peers in Engineering & Manufacturing and from other sites to develop and implement solutions, propose and implement new processes and technologies as alternatives to optimize efficiencies in the departments. Ensure that the site quality organization is staffed, organized, and resourced to fulfill its obligations to comply with US & global regulatory requirements and BD procedures. Develop a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations. Manage performance issues and solicit the appropriate input from HR, stakeholders and management, write and administer performance appraisals on time and in a thorough and thoughtful manner. Manage overall operational leadership in planning and management of quality systems activities, including resource management, which includes the following: Validation program, internal and external compliance / quality audits, non-conforming material, corrective and preventive action program (CAPA board), GMP training program, quality engineering, process and product change control, document control, complaint management. Implement corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations. Interface with external customers/agencies and FDA during audits and inspections. Other duties as assigned. Location Primary Work Location: MEX Tijuana - Parque Sur Equal Opportunity Employer Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr
Gerente De Calidad Sr Emi
BECTON DICKINSON
Tijuana, Tijuana
Publicado hace 5 días
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