Sr. Manager, Quality, Distribution Operations

Sr. Manager, Quality, Distribution Operations

JOB DESCRIPTION SUMMARY:

Operates under direct line supervision to the Sr Manager, Quality, US Distribution Management. Primary responsibilities include assuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations, laws and company’s procedures. The role will provide Quality oversight at company’s large capacity DCs with greater levels of complexity due to the number of business units served, additional services provided such as returns, reboxing, etc. The Sr. Manager, Quality, Distribution Operations assures the local organization and resources adequately support company’s requirements and priorities in order to create customer value addressing elements critical to Business success.

POSITION OVERVIEW

Oversee and assure the DC maintains a robust, standardized and effective Quality Management System which complies with applicable regulatory requirements and Quality Agreements established with business units served. Ensure the DCs’ processes, organization, procedures, and activities are adequate to effectively meet the needs of the US Supply Chain and conform to all applicable regulatory requirements and regional standards. Promote a culture of Quality across the local organization that ensures management commitment and understanding of ISO and QSR regulations as they apply to Storage, Distribution and Transportation. Determine, establish and implement training and development programs that enhance the overall skills of the Quality organization and optimize knowledge, expertise, practical application, performance and succession planning. Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance. Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business. Lead and/or participate in regularly scheduled Quality Leadership calls to ensure timely implementation of agreed upon actions and facilitate cross site exchange of performance and synergistic activities. Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues. Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.

POSITION RESPONSIBILITIES:

• Accountable for management of the Quality Organizations
• Consistent application of Quality System standards (for example ISO 13485, ISO 9001, and 21CFR820)
• Maintains and improves the Site Quality System
• Primary drug representative accountable for meeting all state and licensing board regulations and is the Site Management Representative for governing bodies, including supporting customer and regulatory body audits
• Lead and support site’s CAPA – Effective use of DMAIC process to support CAPA process, detail technical review and approval of the CAPAs to ensure compliance to standard and effectiveness
• Continuously evaluate progress toward NASC Distribution Quality objectives adapting them to meet customer and business needs
• Recommend and initiate projects to resolve nonconforming issue(s), facilitate root cause analysis discussion using appropriate quality tools (for example Fishbone Diagram, 5-Whys), development corrective and preventative action
• Accountable for non-conforming product (hold, SIQ, damages, donation, scrap) processes in a small/medium or less complex distribution center
• Understand Quality Systems Regulatory requirements and application to Company /Unit requirements
• Develop and execute site quality strategy
• Oversee site’s training program and Quality Management System, ensuring that the processes needed for QMS are effectively established, implemented, and maintained in accordance with standard and company’s policy and procedures
• Manage and or support the risk management, quality system documentation, and validation and verification for new or change process
• Handle customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards
• Maintain positive and cooperative communication and collaboration with all levels of management, employees, customer, contractors and vendors
• Collaborates with cross functional partners to seek their input into the development of policies and procedures, Quality System manuals, and their support in addressing Quality Issues
• Guides the successful completion of major programs and may function in a project leadership role for site, regional or corporate initiatives/projects
• Establish, manage and monitor metrics which effectively measure the performance of the US Distribution QMS and ensure appropriate actions are taken and assessed on a regional basis to maintain established targets
• Ensure talent retention and performance management of team
• Mentor and develop site Quality leadership, including dedicated succession planning and contingency management.

EDUCATION AND EXPERIENCE REQUIREMENTS

• BS Degree in Quality Engineering preferred, or related discipline.
• Five to seven years’ Quality experience in Medical Device and/or Pharmaceutical regulated industry.
• Experience in Supply Chain and/or Distribution Center Operations preferred
• Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820
• ISO 13485 and 21 CFR 820 Lead Auditor certified preferred.
• Excellent oral and written communication skills.
• Computer skills (Excel, Word, Power Point, etc.)

For certain roles at our company, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with company’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career with us means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.