Quality Manager

Birmingham, AL

Job Req code: 941

Category: Quality Systems

The Quality Manager oversees the complex quality activities in support of batch record review, product lot dispositioning, and product dispositioning.  The position has interaction with all other internal departments, including Facilities, Quality Assurance, Validation, Calibration, Materials, and Logistics.  The position has and/or supervises interaction with external entities including contractors and suppliers and regulatory agencies. The Quality Manager monitors the compliance level of manufacturing activities by contractor manufacturers by collecting, evaluating and present complex data in a simple and concise manner; monitor performance of a wide variety of complex activities to ensure compliance with applicable regulatory requirements. Serves as the quality representative in project teams; A problem solver with the ability to evaluate quality problems.  The Quality Manager uses risk based approach to implementation of regulatory requirements and problem solving; Must possess excellent communication, organizational, people and managerial skills.

KEY RESPONSIBILITIES

  • Ensures that all Quality management systems conform to quality requirements.

  • Management and development of Quality Coordinators and Supervisor of QC Receiving Coordinator.

  • Oversee incoming product inspection nd batch record review.

  • Ensures that final product and product dispositioning activities are conducted in accordance with quality requirements.

  • Identifies and implements Quality system, process and procedure improvements, as appropriate.

  • Ensures that all documentation administration and documentation practices are performed to meet production needs and are in accordance with quality requirements.

  • Ensures that projects are appropriately supported by Quality and develops creative strategies and resourcing with regard to meeting the project timelines.

  • Performs as Project Leader, as necessary, to further corporate objectives.

  • Prepares and maintains budget, using appropriate resourcing.

  • Oversee Deviations, CAPA, OOS and other Exceptions as needed.

  • Generate trend reports as they relate to quality activities.

  • Revise SOPs.

  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.

  • Identifies and implements issues and opportunities for improvements.

Requirements

TECHNOLOGY COMPETENCIES

Technical and Scientific Proficiency

Demonstrates astute understanding in quality technology practices.

Recognized as a technical resource within the department.

Determine the necessary actions and assign responsibility for each action.

Regulatory Requirements

Assures that industry standards, regulations, and best practices are implemented.  Ensures training to other employees in quality systems and awareness.

Systems Requirements

Identify newer, more advanced, methods and creates a plan for implementation. Monitors and assures compliance in all practices and procedures. Mentors and coaches others in enhancing the Quality System system’s development and continuous improvement.

 

DOCUMENT CONTROL COMPETENCIES

Regulatory Requirements 

 

Influences organizational implementation of new FDA, USP, and other applicable requirements as they relate to documentation.

 

Systems Requirements 

Identify opportunities for improvement within the existing documentation system.

 

Processes/Procedures Compliance Requirements

 

Institute continuous improvement mechanisms. Tracks regulatory requirements and analyzes impact on documentation.

PREFERRED EDUCATION AND EXPERIENCE

  • Requires a Bachelor’s Degree.
  • Minimum of 5+ years of experience in a GMP regulated environment and Quality Management experience.
  • 5+ years of experienced  in managing staff.
  • Experience in Auditing, GMP training, and batch record review a plus.