Regional Quality Systems Mgr

Fresenius Medical Care•Knoxville, TN

About The Position

The Regional Quality Systems Manager provides guidance for site development, deployment and maintenance of strategic quality requirements for Distribution Centers within the assigned region of the country. A seasoned, experienced professional with a full understanding of Quality Systems; resolves a wide range of issues in creative ways. Assures compliance programs are implemented and maintained at the applicable sites within Distribution Centers. Maintains a physical presence at each Distribution Center (DC) within the assigned region a minimum of once per quarter. Works with business partners to mitigate compliance risk at responsible manufacturing sites and provide leadership to the Distribution Center organization. Proactively identifies risk management and compliance leveraging opportunities and interacts and influences both regulatory authorities and industry organizations in decision-making. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Makes decisions regarding the applicability of cGMP and ISO regulations to distribution center operations. Ensures there is a breadth of quality/compliance expertise in all product platforms or product types within FMCNA and provide compliance advice and coverage for all distribution sites. Responsible for the development and maintenance of an active audit program for the performance of required internal and external audits. Formulates and influences policy changes and ensures these changes are implemented across all DC sites. Provides innovative solutions to cross-functional compliance issues, assuring the solution falls within appropriate regulatory guidance's. May advise regulatory agencies or bodies regarding specific programs or processes, when applicable. Ensures key Distribution processes are defined, documented and process controls are in place. Recommendations continual process improvements and participate in the planning and implementing of process changes within the Distribution Centers. May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions. May escalate issues to supervisor/manager for resolution, as deemed necessary. Mentor other staff as applicable. Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

Requirements

Bachelor's Degree in Chemistry or related field required, engineering background a plus; Advanced Degree desirable
5 - 8 years' experience in Quality Assurance, Regulatory Affairs and/or compliance; or a Master's degree with 3 years' experience; or a PhD without experience; or equivalent directly related work experience
Strong knowledge of FDA regulatory requirements and of standard quality assurance practices such as ISO 13485
Thorough technical knowledge of current Good Manufacturing Practices (cGMPs), Good Distribution Practices (GDPs_ and International regulatory requirements
Prior supervisor experience required
Strong oral and written communication skills
Hands-on experience interacting with regulatory authorities required
Detail and goal oriented; must be focused on teamwork and the customer
Strong project management skills with the ability to manage multiple projects
Strong prioritization skills
Strong technical, business and relations skills
Proficient with PCs and Microsoft Office applications
Prior knowledge of compliance training required

Nice To Haves

Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired.
Experience as a health authority or regulator desirable.

Responsibilities

Provides guidance for site development, deployment and maintenance of strategic quality requirements for Distribution Centers
Assures compliance programs are implemented and maintained at the applicable sites within Distribution Centers
Maintains a physical presence at each Distribution Center (DC) within the assigned region a minimum of once per quarter
Works with business partners to mitigate compliance risk at responsible manufacturing sites and provide leadership to the Distribution Center organization
Proactively identifies risk management and compliance leveraging opportunities and interacts and influences both regulatory authorities and industry organizations in decision-making
Makes decisions regarding the applicability of cGMP and ISO regulations to distribution center operations
Ensures there is a breadth of quality/compliance expertise in all product platforms or product types within FMCNA and provide compliance advice and coverage for all distribution sites
Responsible for the development and maintenance of an active audit program for the performance of required internal and external audits
Formulates and influences policy changes and ensures these changes are implemented across all DC sites
Provides innovative solutions to cross-functional compliance issues, assuring the solution falls within appropriate regulatory guidance's
Ensures key Distribution processes are defined, documented and process controls are in place
Recommendations continual process improvements and participate in the planning and implementing of process changes within the Distribution Centers
May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions
May escalate issues to supervisor/manager for resolution, as deemed necessary
Mentor other staff as applicable
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
Assist with various projects as assigned by a direct supervisor
Other duties as assigned