Quality Assurance - Document Control Manager

  This is an experienced person with in depth and specialized knowledge of cGMP documentation.  This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training.  Additionally, they have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements.  They may be assigned duties representing Quality in appropriate situations as defined by their management. 

External US

Essential Functions

• Defines the policies/procedures for document control processes
• Ensure adequate staff levels to meet work goals per schedule timelines
• Managing staff/project related budgets
• Client Audit team DC representative (in room with client auditor)
• Regulatory Audit Team representative (in room with regulatory auditor)
• Liaising with clients regarding DC approvals/business process strategies
• Provide strategy for business related projects (process improvements)
• Represent DC in business teams meetings
• Represent FDBT DC in Global meetings
• Change Control, Deviation and CAPA management
• Writing and revising QA SOP's
• Training, motivating and guiding staff and new hires
• Resolving staff issues and delivering performance reviews
• All other duties as assigned

 

Required Skills & Abilities

• Excellent written and oral communication skills
• Excellent organization
• Experience with Word, Excel, and Adobe
•  

Working Conditions & Physical Requirements

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.  While performing the duties of this job, the employee is regularly required to

• Experience prolonged sitting, some bending, stooping and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to access and utilize computer interfaces for extended periods of time.
• Attendance is mandatory.
• On call availability during some off hours

Qualifications

• High school or equivalent 10 years or more experience in Pharmaceutical or other regulated Industry.
• Associates Degree 7 years or more experience in Pharmaceutical or other regulated Industry.
• Bachelor Degree 5 years or more experience in Pharmaceutical or other regulated Industry. 
• Master's Degree 2 year or more experience in Pharmaceutical or other regulated Industry.
• Supervisory experience 4 years