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Technical Manager, Quality Systems

Novato, CA 94949

Posted: 09/12/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 613547 Is job remote?: No Country: United States

Job Description


Description

This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.  We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.  These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any treatment options.  The company will continue to focus on advancing therapies that are the first or best of their kind.

The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.  These engineers, technicians, scientists and support staff build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.  Come to join our team and make a meaningful impact on patients’ lives.   

Summary Description
The Quality Systems Technical Manager is responsible for ensuring the company's Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.   

Responsibilities: 
  • Participate in inspection readiness, regulatory inspection support and self- inspection activities.
  • Quality system metrics and trending.
  • Works 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.

Education:
  • BS/MS  preferably in the life sciences
Experience:
  • 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Novato, CA

Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.