🌎
This job posting isn't available in all website languages

Senior Quality Leader Manufacturing

📁
Supply
💼
United States
Thanks for your interest in the Senior Quality Leader Manufacturing position. Unfortunately this position has been closed but you can search our 591 open jobs by clicking here.

 

A fantastic opportunity is available for a Senior Area Quality Leader to join our Quality team.

  

 

Responsibilities/Duties

 

  • Provide management for quality, relating to the final responsibility for the release of any vitamin and/or drug products manufactured by RB SLC. The release criteria includes the review and acceptance of all testing data supporting the release of the product against specification; the review and approval of all documentation generated during the manufacturing and packaging processes (batch records); and the overall compliance to cGMP guidelines during the receipt, storage, manufacturing, packaging, and testing of the final product.
  • Coordinates investigation activities, performs root cause analyses, and develops corrective and preventive action plans with the local operations team.
  • Authors/Reviews/Approves a wide variety of technical documents including Deviations, Change Controls, Protocols, Investigation reports, and so on
  • Provide technical guidance and facilitate problem-solving methodologies regarding quality-related issues.
  • This position assures that all standard operating procedures are reviewed and approved by the appropriate Quality Assurance personnel and those procedures and policies comprising the quality system are properly carried out.
  • Assist with the review and approval for Manufacturing, Packaging and Quality Operation processes, GMP documentation including SOPs, Forms, etc.
  • Provide training and guidance to ensure compliance with Regulatory Requirements and Guidance, Standard Operating Procedures (SOPs), Departmental Operating Instructions, protocols and other governing documentation by Operations and Quality personnel.
  • Participate in new product launch and site transfer teams to ensure all applicable regulations and quality objectives are met for launch of products to various global markets.
  • Acts within a team to support international, federal, state and local regulatory officials in regards to the manufacture and release of drug products by RB SLC.  Participates and supports both internal and external audits from a variety of regulatory bodies and other establishments.
  • Provides trend reports to management as required including key performance indicators to ensure QMS is compliant.
  • Assure that annual reports for commercial products are completed in a timely basis.

 

 

Is this You?

  • Demonstrated ability to lead the development and implementation of business / quality processes to assure regulatory compliance, leading cross-functional technical personnel, and coordinating the execution of multiple complex projects in a fast-paced environment.
  • Must have a strong working knowledge of applicable parts of Title 21 of the CFR, ICH, and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical or medical device industry.
  • Experience using electronic quality management tools such as TrackWise is a PLUS.
  • Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem-solving teams, etc.
  • Experience with agents of governmental regulatory bodies as well as internal and external customers and suppliers; participation and support of regulatory audits.
  • Must exhibit excellent communication and facilitation skills, both oral and written.
  • Bachelor’s degree in a scientific or technical field such as Chemistry, Chemical Engineering, Industrial Engineering, Mechanical Engineering, or Manufacturing Engineering.
  • Candidate shall have 5-8 years of quality assurance work experience in a Pharmaceutical/Medical device industry or equivalent.


 

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.

 
 

Apply Now for a chance to really change the game!


 

 
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Previous Job Searches

Activity Feed

12595
Job shares through RB
Darren Hudson referred the Technical Cell Associate position. 13 hours ago
Darren Hudson referred the Technical Cell Associate position. 13 hours ago
Mary Cosh referred the Consumer Insights Manager position. 3 days ago
Kristin Ray referred the Data and Reporting Coordinator position. 4 days ago

Similar Listings

United States

Salt Lake City, Utah, United States

📁 Supply

United States

Salt Lake City, Utah, United States

📁 Supply

United States

Salt Lake City, Utah, United States

📁 Supply