QA Director


Job ID 17-00306

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

JOB TITLE: QA Director

REPORTS TO: Vice President QA & Compliance
DEPT: QA

SUPERVISES: Variable

JOB SUMMARY
Head of Quality
Lead and Direct activities within QA Operations and QA Documentation/Training Departments
Approve quality documents and site/corporate policies as applicable for Client Pharma LLC
Authorized Management Representative and Point of Contact for all regulatory US FDA and Client inspections Chair Site Management Quality Review Meetings

REPORTING RELATIONSHIPS
Senior QA Manager
QA Documentation
DEA Manager
QA Compliance Specialist
QA Investigator

DUTIES & ESSENTIAL JOB FUNCTIONS
The responsibilities in general include but not limited to the following and may change at the discretion of Head of QA

DUTIES & ESSENTIAL JOB FUNCTIONS
PERCENT OF TIME FREQUENCY ESSENTIAL DUTIES (List in order of importance – most significant first)
40 Daily Monitoring activities within QA Operations, Compliance and QA Documentation Departments
Walk-through of the facility and work with cross functional areas to assess QA support.
40 Daily Approval of Quality Documents and policies as applicable
5 Daily Attend management and/or issue resolution meetings as applicable
5 Monthly/Quarterly Prepare Quality Review Metrics and Present to the Management as applicable
5 Yearly Lead audits for the FDA and Clients. Prepare audit responses
5 Yearly Attend Client meetings
     



OTHER FUNCTIONS AND RESPONSIBILITIES
And perform other duties as assigned



Qualifications

QUALIFICATIONS
Minimum 10 years of management experience in leading Quality/Quality Assurance in Pharmaceutical Industry Experience in leading regulatory and client inspections, preparation of responses and acting as a liaison between the regulatory agency and the company
Experience working with cross-functional areas and corporate divisions Experience in handling Recalls and Field Alerts
Experience with the DEA is preferable

REQUIRED
BS or higher degree in life sciences
Good written and verbal communication

ANY REQUIRED LICENSES/CERTIFICATIONS
ASQ certification preferable