Senior Manager, Quality

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.
• Work overtime as dictated by business whether mandatory or voluntary.

CORE COMPETENCIES

Independent Contributor

Accountability

Communication / Building Partnership

Customer Orientation

Developing Oneself

Drive for Results

Embracing Change

Problem Solving

Professional Competencies

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.