Quality Assurance Director

Job Description

Manages and coordinates all affairs related to the Quality Assurance Unit. The Director assures compliance with all FDA, cGMP, and similar regulatory quality requirements

SKILLS/KNOWLEDGE AND/OR ABILITIES

• Capable of comprehending written regulations, especially regarding the development, manufacturing, and distribution of drug products
• Thorough knowledge of cGMP regulations, USP and International Conference on Harmonization (ICH), and an understanding of the technical, regulatory, and commercial aspects of pharmaceutical products
• Demonstrated record of successful interaction with FDA and other regulatory agencies and other internal and external auditing groups
• Demonstrated ability to interface effectively with senior management, auditors, and regulators
• Ability to use good judgment in diligently investigating and finalizing problems
• Skills in maintaining cooperative working relationship with other Personnel and departments
• Aptitude for recognizing and dealing with priorities
• Demonstrated experience with statistical analysis, raw materials and finished products specifications, laboratory procedures, chemical analyses and manufacturing processes
• Ability to perform internal and external audits
• Ability to train and coach personnel in QA and other departments

MENTAL

• Mathematics: Proficient math skills, including knowledge of exponential mathematics and advanced statistical methodology
• Sciences: Good basic working knowledge of biological and physical science
• Language: Read, write, and speak English well enough to communicate effectively and prepare grammatically-correct reports
• Mechanical: Minimum. Must be able to understand basic operations of chemical, physical, and biological instrumentation and operations
• Spatial: Ability to observe and notice abnormal conditions
• Computers: Competent skills in use of computer programs are required.

AUTHORITY

• Has the authority to take action to meet the responsibilities and perform the duties described herein within the limitations established in the Corporate Operating Procedures

GENERAL RESPONSIBILITIES

• Responsible for understanding COP mandates
• Responsible for learning and understanding relevant regulations mandated by Federal, State, local, and foreign agencies
• To advise the President, COO, officers, and managers about applicable regulations
• Responsible for coaching departmental managers about regulations which affect them

SPECIFIC DUTIES AND TASKS

• Review and/or develop protocols for conducting tests or validation techniques necessary for approval of facilities or products, especially mandated by FDA, USDA, etc.
• Plan and execute Quality Assurance strategies and procedures to assure compliance with regulatory requirements
• Define and direct corporate quality policies, qualifications, and validations.
• Develop, direct, monitor, evaluate, document, and communicate quality assurance program
• Respond in a timely manner to inspection reports, such as FDA Form 483. Must be able to develop responses to FDA’s requests during routine inspections and special requests within two weeks and based on team action and input of relevant personnel
• Assist Regulatory Affairs and Quality Control to diligently prepare annual drug reviews
• Investigate customer complaints
• Work on special projects as assigned
• Maintain work areas in a neat and orderly manner

OTHER CRITERIA

• Seek guidelines and direction as necessary for the duties performed.
• Make the best use of time during work period
• Assure responsibility for staying aware of policy and procedure changes
• Assure responsibility for the ethical and correct production of consumable products
• Perform other duties which may be required or assigned from time to time

SPECIAL SPECIFIC DUTIES
FINAL REVIEW AND RELEASE OF:

• Containers, components, closures
• Labels and labeling materials
• In-process and finished products

MEASURES OF PERFORMANCE:

• Maintenance of product quality
• Timeliness of project completion
• Efficient use of funds and resources
• Proper maintenance of records
• Proper compliance with external and internal regulations and COPs
• Maintenance and improvement of employee attitude, especially within project resources personnel

REPORTING RELATIONS
Reports to: President, Chief Operating Officer or CEO
Supervises: Quality Assurance Managers, Supervisors and Quality Assurance Reviewers

REQUIREMENTS
EDUCATION
Required: Baccalaureate degree in Chemistry or Pharmacy
Preferred: Advanced degree in Chemistry or Pharmacy

LICENSING/REGISTRATION/CERTIFICATION
Required: None
Preferred: Quality Assurance Certification

EXPERIENCE
Required: 10 years experience directly related to pharmaceutical manufacturing and quality assurance operations
Preferred: 5 years of personnel supervision and management