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Quality Technical Manager

San Rafael, CA 94901

Posted: 08/16/2024 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11825 Pay Rate: $52.00 - $62.00 Remote Friendly: Onsite

Job Description

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Duties:
  • The Quality Systems Technical Manager is responsible for ensuring our client's Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.
  • Participate in inspection readiness, regulatory inspection support and self- inspection activities.
  • Quality system metrics and trending.
  • Work cross functionally with management within and outside Technical Operations to ensure consistency of use of the quality systems.
  • Participate in quality system improvement and process mapping initiatives.
  • Author and own site Quality Technical Agreements.

Job Requirements

Skills:
  • 6+ years experience in pharmaceutical or related industry.
  • Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.
  • Ability to comprehend technical information related to analytical methods, manufacturing processes and regulatory expectations.
  • Familiarity with FDA, European and international regulatory requirements.
Education:
  • BS/MS preferably in the life sciences.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!