Senior Manager, Quality Control - #1413782

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 r esponsible 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

Essential Duties And Role 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

Required Skills And Experience

• 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

California residents should review our Notice for California Employees and Applicants before applying.

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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