Quality Systems Manager – Distribution Ops.
A career connection worth making
Meaningful connections. For someone with a renal condition, the smallest level of support and dependability can mean the world. That’s why Fresenius Medical Care North America is constantly looking for talented individuals who are focused on one thing: helping people live better lives. By joining a leading provider of renal care products and services, you’ll enjoy incredible growth and stability, but you’ll also play an important role in providing the consistent care that can make a real difference in our patients’ treatments. Now that’s a connection worth making.
Quality Systems Manager - Distribution Ops.- Eastern US
An outstanding opportunity to work at Fresenius Medical Care North America. Fresenius is the world's largest, integrated provider of products and services for individuals with chronic kidney failure, a condition that affects more than 1,300,000 individuals worldwide. Through its network of over 49,000 employees in over 100 countries, FMCNA offers outstanding career opportunities across the globe in a rapidly expanding yet stable environment . Working at Fresenius means growing your career while making a difference.
Responsible for assuring that compliance programs are implemented and maintained at the applicable sites within Distribution Centers.
Responsible for working with business partners to mitigate compliance risk at responsible manufacturing sites and provide leadership to the Distribution Center organization..
Responsible for proactively identifying risk management and compliance leveraging opportunities and interacts and influences both regulatory authorities and industry organizations in decision-making. The incumbent also makes decisions regarding the applicability of cGMP and ISO regulations to distribution center operations.
This position will eventually manage a group of Compliance personnel in order to accomplish compliance goals. The position must develop this group, ensuring 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.
Responsible for formulating and influencing policy changes and ensures that these
Bachelor`s degree in Biology, Chemistry or related field is required.
Strong knowledge of FDA regulatory requirements and of standard quality assurance practices such as the ISO 13485.
Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired.
Engineering background a plus.
Thorough technical knowledge of cGMPs and International regulatory requirements.
A minimum of 5-7 years of experience in Quality Assurance, Regulatory Affairs and/or Compliance is required.
Prior supervisory experience is required.
Must possess the ability to effectively communicate requirements and regulatory issues.
Hands-on experience interacting with regulatory authorities is required. Experience as a health authority or regulator is desirable.
Detail and goal oriented; must be focused on team work and the customer
Ability to manage multiple projects.
Strong prioritization skills.
Must be able to adapt to the business needs.
Strong technical, business and relations skills directed related to a broad range of compliance areas.
Strong leadership abilities
Strong communication verbal and written skills.
Strong conflict and change management skills.
Ability to influence an
Fresenius offers highly a competitive benefits package that includes medical and dental, 401k, short- and long-term disability, tuition reimbursement, and a paid time off program. Fresenius Medical Care is an Equal Opportunity Employer. For more information please visit our website at www.fmcna.com . Please apply on-line at www.fmcna.com .
