What are the responsibilities and job description for the Senior Manager, Quality Control position at Kindeva Drug Delivery?
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
Essential Duties And Role Responsibilities
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
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
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
- 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
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!