Senior Manager, Quality

at DSV Air & Sea Inc. in Aurora, Illinois, United States

Job Description

If you are a current DSV employee and interested in a position in another country,please contact your Human Resource representative to discuss the process and requirements of applying.

Job area:
 
 Managerial

DSV - Global transport and logistics
In 1976, ten independent hauliers joined forces and founded DSV in Denmark. Since then, DSV has evolved to become the world's 3rdlargest supplier of global solutions within transport and logistics. Today, we add value to our customers' entire supply chain by transporting, storing, packaging, re-packaging, processing and clearing all types of goods. We work every day from our many offices in more than 80 countries to ensure a steady supply of goods to production lines, outlets, stores and consumers all over the world. Our reach is global yet our presence is local and close to our customers. Read more at www.dsv.com
Location: [[Aurora, IL]]
Division:[[Solutions]]
Job Posting Title: [[Senior Manager, Quality]]
Time Type: [[Salary]]

POSITION SUMMARY

Senior Quality Manager
The holder of this role is accountable for continuous compliance with DSV's Quality Management System and health authority regulations for medical device, pharma handling and distribution. To formulate and execute the country quality strategy and be the single point of contact for Quality Compliance for the network branches under responsibility.

***This role can be based in Lawrenceville, GA; Aurora, IL; Port Reading, NJ; Lancaster, TX; Fontana, CA; or virtual***

ESSENTIAL DUTIES AND RESPONSIBILITIES

KEY RESPONSIBILITIES
Lead the Healthcare QMS implementation and maintenance in the responsible branches.
Author, review and approve local QMS documentation including procedures, operational standards, working instructions, guides etc.
Ensure availability of all local and international certificates and licenses required for handling healthcare products.
Effectively manage non-conformities and customer quality complaints through adequate investigations and root cause analysis.
Ensure healthcare facilities and IT systems are adequately qualified and validated.
Participate in Self-inspections, Customer audits, Regulatory inspections, and certification audits. Ensure timely and adequate corrective actions are put in place.
Perform audits of business partners and ensure quality technical agreements are in place with all approved business partners.
Make sure data integrity requirements are met and all QMS documents and records are adequately handled and stored.
Report quality status and related metrics to local and global healthcare management.
Identify training needs and working closely with local quality managers, develop a consistent and effective training plan.
Regularly exchange information with Country/Branch Managers to continuously improve quality culture and compliance. Share best practices with other countries/branches.

SKILLS & ABILITIES

Education & Experience:
Degree in pharmaceutical or life sciences
At least 5 years of experience working in a pharmaceutical quality assurance function.
Experience working in a 3PL environment.
Experience leading site quality operations
Healthcare regulatory experience, including GDP, cGMP, FDA/ DEA requirements.
Strong communication and presentation skills
Good interpersonal skills with the ability to communicate with functions at different levels and regulatory authorities.
Knowledge of document control systems and procedures and good proficiency with Microsoft office tools.
Ensure availability of all local and international certificates and licenses required for handling the healthcare products.

Computer Skills:
Good proficiency in Microsoft office tools
Good understanding of computerized system validation in GxP environment

Certificates & Licenses: NA

Language Skills:
English (reading, writing, verbal)
Interpersonal communication and language skills (e.g., listening to others, speaking to others, reading, writing)
Communication (facilitation skills and very mature communication skills to be able to communicate to all levels in the organization)
Strong executive... For full info follow application link.

DSV is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, veteran status, marital status, gender identify, sexual orientation, national origin, liability for military service, or any other characteristic protected by applicable federal, state or local law. If you require special assistance or accommodation while seeking employment with DSV, please contact Human Resources at hr@us.dsv.com. If you are interested in learning the status of your application, please note you will be contacted directly by the appropriate human resources contact person if you are selected for further consideration. DSV reserves the right to defer or close a vacancy at any time.