Director of Quality - Biologics
Mantell Associates is currently working on an exciting opportunity for an experienced professional to lead as Director of Quality.
Reporting directly to the Vice President, Quality, this role encompasses overseeing all quality-related efforts associated with the manufacturing and testing of pharmaceutical products.
Your leadership and expertise will drive compliance with industry regulations and continuous improvement initiatives, shaping the future of quality operations.
Director of Quality - Responsibilities :
- Set ambitious departmental goals and provide guidance to the Quality Unit team
- Direct Quality Control, Quality Assurance, and Quality Projects teams to excellence
- Ensure seamless product transfer processes, adhering to cGMP requirements
- Design and review investigational plans for deviations, CAPAs, and laboratory investigations
- Implement policies and initiatives to enhance professional capabilities and efficiencies
- Coordinate and manage multiple projects, optimizing budgets and driving cost-saving measures
- Develop, utilize, and report metrics for performance evaluation and goal setting
- Maintain readiness for customer audits and regulatory inspections
- Embrace Health and Safety Policy and tackle additional duties as assigned
Director of Quality - Requirements :
- Bachelor of Science or equivalent experience in Analytical Chemistry, Biochemistry, or related discipline
- Ten years of relevant industrial experience
- Knowledge of cGMP, ICH, FDA guidelines, and pharmaceutical manufacturing processes
- Demonstrated leadership and project management skills
- Strong motivation, resourcefulness, and communication abilities
- Proficiency in computer skills and organizational capabilities
- Leadership Competencies :
- Emotional intelligence
- Leverage Diversity
- Organizational Intelligence
- Develop Others
- Facilitate Transformation
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.
Director of Quality - Biologics
Mantell Associates is currently working on an exciting opportunity for an experienced professional to lead as Director of Quality. Reporting directly to the Vice President, Quality, this role encompasses overseeing all quality-related efforts associated with the manufacturing and testing of pharmace...
Director of Quality Assurance
Proficient with Microsoft Office specially with Microsoft Office 365, such as Teams, SharePoint, Excel, PowerPoint CRM software along with creating forms using pdf fillable formats and Microsoft forms. Minimum of 5 years experience within the field of quality assurance/accreditation/quality improvem...
Quality Assurance Lead
Quality Assurance Lead in Canada. ...
Quality Assurance Manager
You will oversee Quality Assurance programs, handle complaint management, and implement process improvement initiatives to enhance efficiency, quality, and customer satisfaction within MSH Americas. Manage, coach, and develop the Quality Auditor team. Lead Quality Assurance and cross-functional team...
Senior Quality Engineer
We are looking for a curious, details-oriented Senior Quality Engineer who is skilled in both manual and automated testing. Quality Engineering is an integral part of the product-development team and closely involved in every step along the way - from ideation of the project, during implementation, ...
Technical Project Manager
A Technical Project Manager leads a team of individuals, or groups of teams and plays a leadership role in scoping requirements with customers, analyzing project goals, and creating a plan to achieve those goals. Technical Project Managers are responsible for managing scope, schedule, and cost while...
Sr Quality Assurance Engineer
The Senior QA Engineer position supports Graebel's web application and API services. Continuous Integration: Integrate automated tests into the CI/CD pipeline ensuring continuous quality. Follow established team testing practices to ensure the highest quality through clearly documented and repeatabl...
Construction Project Manager, Civil
Constructoin Project Manager, Construction Site Engineer, Civil Engineering. Work with the client from the start of each project to ensure you understand the project scope and vision. Manage special projects end to end. Analyze photographs, drawings and maps to inform the direction of projects as we...
Quality Assurance Lead for Inforce Insurance
Quality Assurance lead will have mastered the Quality Assurance Specialist responsibilities plus:. The Quality Assurance Lead will report to the Manager, Inforce Insurance Training & Quality while working closely with other QA(s) and leaders. As a Quality Assurance Lead, you will be providing perfor...
Quality Manager
Under the direction of the Director of Quality, it is the Quality Manager's responsibility for managing all aspects of the quality processes and programs, and ensure the timely completion and meeting of expectations for all Quality-related projects and elements, while maintaining long-term stakehold...