QA Manager- Global Quality Management & Projects

Job Title

QA Manager

Job Grade

G10

Department

Global Quality Management & Projects

FLSA Classification

Exempt

Manager’s Job Title

QA Manager

Department Head Title

Global Quality Management & Projects

Does This Position Have Any Direct Reports?

No

Job Summary

Responsible for QMS Track wise module related to Laboratory, Investigation Review Board and Quality Review Board.

Area Of Responsibility

• Assist with creating short and long term project plans, setting targets for milestones and adhering to timelines.
• Lead meetings with global and site teams to complete projects as assigned.
• Working with external parties to ensure deadlines are met and expectations are met.
• Ensuring day-to-day operations of assigned projects are on track and escalated if targets are falling short, to ensure milestones are achieved.
• Prepare and present materials internally and externally when required.
• Communicating with management ensuring project(s) is/are aligned with goals.
• Performing quality control on projects to ensure expected outcomes are delivered.
• Extensive knowledge of cGMP, ISO, and other relevant regulations and guidelines
• Knowledge of quality systems and processes, including CAPA, change control, risk management, etc.
  
  

Physical Requirements

• While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear.
• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes, if required.
  
  

Travel Estimate

Up to 5%

Education and Job Qualification

• Minimum of Bachelor’s degree.
• Excellent interpersonal and communication, both written and verbal, skills.
• Strong organizational and time management skills; must be a ble to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
  
  

Experience

• Minimum of (15) years of experience within the pharmaceutical industry in quality function role.
• Experience working in an international multicultural matrix organization.
  
  

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).