Senior Manager, Quality Control

Kindeva Drug Delivery•Los Angeles, CA

35d•Onsite

About The Position

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Quality Control Senior Manager is responsible for the overall management of the Quality Control Laboratory, ensuring all activities comply with regulatory standards and company specifications. Additionally, they will ensure support to the operations business plan with respect to the QC Laboratory. The QC Senior Manager will set the strategic direction of the Laboratory with the site management team, and benchmarking to drive productivity improvements. The role involves liaison with external customers, regulatory agencies, and project teams to provide expert advice on matters relating to QC Laboratory testing and processes. Role is accountable for ensuring all timelines are met, establishing and managing budgets for the entire QC Laboratory. Partners with engineering, production, and other site functions to maintain and increase the quality level within the organization

Requirements

Bachelor’s degree or higher in a science discipline
Minimum 7 years’ experience within a pharmaceutical laboratory
Minimum 5 years’ Supervisory experience
Demonstrated knowledge of current Pharmaceutical guidelines and regulations.
Extensive analytical testing experience within the Pharmaceutical industry

Responsibilities

Provide leadership, direction, and support to Quality Improvement Programs within the Quality Laboratory using Six Sigma Principles
Provide support and guidance to QC Managers with regard technical issues, employee issues, company policy, site processes and Good Manufacturing Practices (GMP).
Maintain the documentation required for their personal EPR process, including training records and complete regular reviews for direct reports and input into MTR processes.
Ensure QC Managers are appraised, have regular access to 1:1 sessions, have clear job descriptions of routine accountabilities, plus additional SMART objectives as well as development and training plans as appropriate.
Interact with customers through technical interfaces and audits. Be available to support the QC Manager in discussions related to significant quality issues with customers, in compliance with Quality Agreements, and favorably present Kindeva’s position.
Management of resource planning for the QC Laboratory set through the S&OP process and effectively manage daily quality and compliance issues together with medium to long-term strategic project plans aligned with business goals and objectives.
Preparation and input into management decision making processes for the QC Department, steering teams, and strategic site meetings.
Provide oversight to the Quality Laboratory Systems
Champion the Development and execution of the site’s compliance programs and training initiatives.
Ensure QC Managers have closed audit actions in the Laboratory within the established timelines. Accountable for the financial planning and delivery of agreed department budget goals and objectives