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 3rd largest 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]]
FRAUD ALERT: Please note that DSV will never request a chat interview or solicit funds from applicants or employees through its interviewing and hiring process. We do not require any form of payment and will not ask for personal financial information, such as credit card or bank account number. Our recruiters have an @dsv.com or @us.dsv.com email address. If you question the legitimacy of any DSV job posting, please reach out to HR@us.dsv.com.
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 presence and ability to simplify complex concepts for consumption by non-technical executives.
Mathematical Skills
- Good mathematical skills
- Financial acumen
Other Skills:
- Experience in leading and/or working with cross-functional teams from design through the implementation.
- Must be able to work in unregulated temperatures within the warehouse during the warmer and colder months can range from mild to moderate.
- Work overtime as dictated by business whether mandatory or voluntary.
CORE COMPETENCIES
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PHYSICAL DEMANDS
Ability to Lift/Carry and Push/Pull
21-50 pounds
Reach above shoulder, reach outward, squat, or kneel.
Other Physical Requirements: While performing the duties of this job, the employee uses his/her hands to finger, handle or feel objects, tools or controls; reach with hands and arms; stoop, kneel, or crouch; talk or hear. The employee uses computer and telephone equipment. Specific vision requirements of this job include close vision and distance vision. Must be able to travel by plane and automobile.
WORK ENVIRONMENT
While performing the duties of this job, the employee rarely is exposed to fumes or airborne particles, toxic or caustic chemicals. The noise level in the work environment is usually low to moderate.
The physical demands and work environment characteristics described above are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this position description and/or assign tasks for the employee to perform, as the Company may deem appropriate.
DSV is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, disability, veteran status, marital status, gender identity, sexual orientation, national origin, 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.
DSV – Global transport and logistics
DSV is a dynamic workplace that fosters inclusivity and diversity. We conduct our business with integrity, respecting different cultures and the dignity and rights of individuals. When you join DSV, you are working for one of the very best performing companies in the transport and logistics industry. You’ll join a talented team of approximately 75,000 employees in over 80 countries, working passionately to deliver great customer experiences and high-quality services. DSV aspires to lead the way towards a more sustainable future for our industry and are committed to trading on nature’s terms.
We promote collaboration and transparency and strive to attract, motivate and retain talented people in a culture of respect. If you are driven, talented and wish to be part of a progressive and versatile organisation, we’ll support you and your need to achieve your potential and forward your career.
Visit dsv.com and follow us on LinkedIn, Facebook and Twitter.
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Senior Manager, Quality
Nearest Major Market: Aurora
Nearest Secondary Market: Chicago