Quality Systems Manager, Document Control and Training - Morrisville, NC | Biospace
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Quality Systems Manager, Document Control and Training

Novan

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Location:
Morrisville, NC
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Pharmaceutical, QA,

Job Description

Purpose:

Reporting to the Associate Director of Quality, the Quality Systems Manager will provide oversight and direction for Novan's Document Management and Training Quality Systems:

Programs and processes include but are not limited to:
•Controlled document processing, issuance, and change control
•Document storage and archiving
•Record retention program
•Good documentation practices
•Electronic records and data management
•Management of document templates
•Improve the Novan training system through development of a company-wide approach to training that encourages personal and professional continuous improvement.
•Develop, maintain, and deliver training course material in support of cGMP regulations and practices

Principal Responsibilities and Accountabilities:
1.Manage the entire document lifecycle including document issuance, format review, routing documents for review and approval, scanning and filing documents in the Master Control EDMS and maintaining hard copy original files as applicable.
2.Support Novan functional groups in collecting and maintaining files of the latest revision level necessary to support the manufacturing process (i.e., SOPs, batch records, specifications, equipment and maintenance records, cleaning records, product and laboratory records, logbooks, deviations, change controls, investigations etc.), as well as facilitate the obsolescence, cataloguing and archival process of previous revisions.
3.Establish a complete and accurate index of Novan documents maintained by the Quality organization. Maintain paper and electronic files in the Company's quality document management system in accordance with Company document lifecycle policies and procedures, federal regulations, and audit requirements. Manage GxP retention and archival schedule as well as off-site storage vendor to archive and retrieve documents as necessary.
4.Lead the implementation and company-wide training efforts in support of cGMP activities. Consolidate and assign company-wide training curriculum per departmental management requirements. Maintain accurate and up to date training records.
5.Develop, maintain, and deliver training course material in support of cGMP regulations and practices
6.Lead periodic Quality audits of documents and records to ensure regulatory compliance and provides support for the quality management system during external and internal audits, including regulatory inspections.
7.Develop, maintain and report metrics designed to support the continuous improvement of Novan's Quality Systems

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

Novan, Inc. is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

Requirements

Qualifications:
1.Education - Two year associates degree required. Bachelor's degree strongly preferred in a life sciences discipline or equivalent.  
2.Experience:
•3 to 5 years of leadership experience in pharmaceutical Quality Systems, preferably Document Management and/or Training systems.
•Development and implementation of pharmaceutical quality systems
•Working with Master Control as an EDMS is strongly preferred
•Supporting third party and regulatory inspection activities through either direct interaction with auditors or management of document flow during inspection.

Skills:
•Ability to develop a forward looking vision for Novan's quality systems and take the incremental steps necessary to ensure compliant systems are in place for a growing business.
•Superior attentiveness to detail; highly organized and process-oriented.
•Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills and ability to interact with all levels of management.
•Ability to compile metrics (i.e., training metrics, compliance metrics, etc.) as well as prepare and facilitate formal presentations for Novan functional groups and Senior Management.
•Ability to facilitate cross-functional training.
•Effectively prioritize workload and manage time to complete multiple projects within established timelines and goals in a fast-paced, interrupt-driven environment.
•Expertise in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, PowerPoint, Adobe and SharePoint.