Regulatory Compliance Mgr

Aspire to achieve the highest quality standards

At Hospira we take our responsibility for work that saves lives seriously. As a provider of innovative medication-management and healthcare work-safety solutions, Hospira is a leader in our market, manufacturing technology, and customer service.

As an entrepreneurial, proactive company, we?re at the forefront ? often ahead of mandates ? in protecting healthcare workers against injury, reducing medication errors, and improving patient safety. We?re renowned for our breadth of product, the absolute cleanliness of our plant, and the high caliber of our people? goal-oriented individuals who are focused on quality and execution.

Regulatory Compliance Mgr
In this role you will provide the direction to site managers for CGMP and DEA requirements and expectations. You will also supervise a group of exempt and non-exempt staff who will conduct the following:
CGMP audits of all operations areas
Serve as the acting DEA coordinator and interface with corporate offices for drug enforcement agency issues
Interface with food and drug officials during site inspections
Interface with third party company officials during site CGMP audits
Lead efforts to educate the site on Hospira quality management system policies
Lead a group of exempt staff who investigate quality issues and prepare formal reports, as well as assure that all CAPA?s have been identified and demonstrate effectiveness over time

In addition, you will manage the site complaint investigation function and, as such, interface with the corporate organization managing this function corporately.

To be successful in this position, you must possess:

Bachelors degree or higher
Several years of experience in the pharmaceutical industry (ideally 5-10 years)
At least 3 years in a quality compliance role as well as several additional years in other quality unit functions is preferred
Experience in manufacturing/engineering is beneficial
Experience in quality business unit- especially quality compliance

Hospira offers a balanced work culture as well as competitive compensation and benefits. As a leader in our industry, we offer tremendous opportunities, tools and resources for motivated individuals to advance in their careers.

To what do you aspire?

Learn more about us and apply online:

https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?jobId=76672&type=search&JobReqLang=1&recordstart=1&JobSiteId=5100&JobSiteInfo=76672_5100&partnerid=16015&siteid=5100

Req #: 2476BR

As an equal opportunity/affirmative action employer, Hospira embraces diversity of thought and cultural perspective and fosters an environment of empowerment, fairness and respect.