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Quality Assurance Manager

Kelly Services

Lakewood, CO
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Quality Assurance Manager

Jobid US15TPCS_BH1436718

Location: Lakewood, CO, 80232, USA

Description QMS Global Process Owner-Document, Record and Change Control

**JOB SUMMARY Direct Hire Position 100K-105K**

Leads the specified global process for the Quality Management System (QMS). Manages a team of direct and indirect reports in a Matrix organization to manage all aspects of the global process. Guides the organization in the appropriate use of the processes and procedures. Is the subject matter expert on all relevant regulations in the markets we serve. Creates or updates procedures to meet these regulations changes. Working with the Director, creates the vision for a refined future state process and works to continually improve.


+ As the subject matter expert for the Document, Record and Change system, the process owner will need expertise in Document and Record lifecycle management and the Change Control process. Document and Record management lifecycle includes all steps between creation and obsolescence for all QMS documents. Change control includes the following steps; initiation, assessment, implementation, execution, effectiveness and closure.
+ Acts as the global policy / procedure owner for areas of responsibility, ensuring they are compliant and effective.
+ Leads Collaboration (Centers of Excellence) groups with site process owners to ensure process consistency at all sites.
+ Serves as expert and main point of contact for regulatory / compliance issues within areas of responsibility.
+ Ensures execution in accordance with policies / procedures and external standards and regulations. This likely includes:generation and approval of schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussions with participants and stakeholders to ensure success and compliance.
+ Monitors the health of the QMS and monitors site and corporate metrics to demonstrate continuous compliance.
+ Identifies and implements continuous improvement opportunities within their areas of responsibility.
+ Influences the organization in quality objectives, prioritization and resourcing decisions.
+ Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
+ Acts as a champion for quality initiatives aimed at improving business systems and compliance; may be the primary Quality representative on projects.
+ During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for Quality.
+ Interfaces with global and site QMS process owners and project teams from all locations & regions to ensure consistency in approach and inspire continual improvement of processes.

**Education/Experience:** 7 years experience in Quality Assurance, Regulatory Affairs with US FDA Class II medical device, Pharmaceuticals, combination products and the worldwide equivalents. Interpretation and application of global regulation changes to quality systems. Experience leading diverse global teams through significant change.

**BS degree in a hard science**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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