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Director QA Life Science and Healthcare
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Westerville, Ohio |
About this job
Memphis area Director of Quality with Medical Device experience
Director QA Life Science and Healthcare
Are you a motivated, organized individual seeking a challenging and rewarding opportunity in a fast-paced environment?Would you enjoy being part of a dedicated team that works together to create a relevant, memorable difference in the lives of our customers and employees?If you're looking for change, and you're ready to make changes … we're looking for you.
DHL Supply Chain is a world-class company, and we hire world-class people. People who aren't afraid to work hard – in fact, people who want to work hard.
Job Description
Develop, plan and coordinate quality assurance activities for the sector, accommodate requests for support from sites and provide the policies and procedures in support of the business.Act as a subject matter expert regarding governmental regulations.Lead key FDA and other regulatory audits.Determines policy and procedures for Life Science sites.Manages and oversees site quality managers/coordinators.Supports new pursuits through documentation requests and onsite audits.Interfaces with DHL Supply Chain's customers when issues and significant quality events occur.Supports global and cross-sector QA initiatives as required.Supports global and cross-sector QA initiatives, existing / potential customers, regulators, and vendors as required.Develops and implements validated processes for regulated hardware and software systems.
• Compiles and analyzes quality metrics and KPI's to determine overall compliance
• Ensures quality compliance at Life Science sites by assessing performance to cGMP, the contract, and customer requirements; reporting the results to executive management.
• Recruits, develops, coaches, mentors and force ranks QA resources for succession planning purposes to ensure that the quality system is consistently and effectively applied across the sector.
• Interface with the Life Science customers for new quality requests, initiatives, and concerns.
• Report status of the QMS to executive management and site management.
• Develop and implement quality-related training programs for management, field operations and QA associates.
• Develop, distribute and maintain management reports.
• Understand customer's business requirements and underlying concerns, develops strong working relationship and trust with customers
• Work co-operatively and collaboratively with all levels of DHL Supply Chain management and departments
• Actively develops the required networks and partnerships to deliver a successful compliance strategy.
• Interacts with regulatory agencies and coordinates ISO certification activities as appropriate.
• Monitors safety and security compliance and collaborates with the respective departments to effect change.
• Manages departmental finances and spending in accordance to budgetary requirements.
Required Education and Experience
• BA or BS in related field of study, required
• 10 years of relevant experience in a cGMP environment with FDA interactions, required
• Experience conducting/leading a successful ISO registration of a relatively large and complex organization and subsequent management of the quality system and organization, preferred
Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.
Our Organization is an equal opportunity employer.
Director QA Life Science and Healthcare
Are you a motivated, organized individual seeking a challenging and rewarding opportunity in a fast-paced environment?Would you enjoy being part of a dedicated team that works together to create a relevant, memorable difference in the lives of our customers and employees?If you're looking for change, and you're ready to make changes … we're looking for you.
DHL Supply Chain is a world-class company, and we hire world-class people. People who aren't afraid to work hard – in fact, people who want to work hard.
Job Description
Develop, plan and coordinate quality assurance activities for the sector, accommodate requests for support from sites and provide the policies and procedures in support of the business.Act as a subject matter expert regarding governmental regulations.Lead key FDA and other regulatory audits.Determines policy and procedures for Life Science sites.Manages and oversees site quality managers/coordinators.Supports new pursuits through documentation requests and onsite audits.Interfaces with DHL Supply Chain's customers when issues and significant quality events occur.Supports global and cross-sector QA initiatives as required.Supports global and cross-sector QA initiatives, existing / potential customers, regulators, and vendors as required.Develops and implements validated processes for regulated hardware and software systems.
• Compiles and analyzes quality metrics and KPI's to determine overall compliance
• Ensures quality compliance at Life Science sites by assessing performance to cGMP, the contract, and customer requirements; reporting the results to executive management.
• Recruits, develops, coaches, mentors and force ranks QA resources for succession planning purposes to ensure that the quality system is consistently and effectively applied across the sector.
• Interface with the Life Science customers for new quality requests, initiatives, and concerns.
• Report status of the QMS to executive management and site management.
• Develop and implement quality-related training programs for management, field operations and QA associates.
• Develop, distribute and maintain management reports.
• Understand customer's business requirements and underlying concerns, develops strong working relationship and trust with customers
• Work co-operatively and collaboratively with all levels of DHL Supply Chain management and departments
• Actively develops the required networks and partnerships to deliver a successful compliance strategy.
• Interacts with regulatory agencies and coordinates ISO certification activities as appropriate.
• Monitors safety and security compliance and collaborates with the respective departments to effect change.
• Manages departmental finances and spending in accordance to budgetary requirements.
Required Education and Experience
• BA or BS in related field of study, required
• 10 years of relevant experience in a cGMP environment with FDA interactions, required
• Experience conducting/leading a successful ISO registration of a relatively large and complex organization and subsequent management of the quality system and organization, preferred
Our Organization has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.
Our Organization is an equal opportunity employer.