Manager of Quality Systems Engineering

2 weeks ago

Novato, California, United States Randstad Life Sciences US Full time

At Randstad Life Sciences US, we pride ourselves on being a dynamic and collaborative organization where our team members are versatile, empowered, and encouraged to take initiative.

We seek individuals who possess a high degree of energy, motivation, and organizational skills, as well as the ability to inspire and lead others.

The Technical Operations division plays a crucial role in the development of our pharmaceutical products for clinical trials and the subsequent scaling for commercial distribution. Our team of engineers, technicians, scientists, and support personnel are dedicated to constructing and maintaining state-of-the-art manufacturing processes and facilities. They ensure compliance with regulatory standards through quality assurance and quality control, while also managing the procurement of essential goods and services to facilitate manufacturing and the global distribution of our products to patients in need. Join us in making a significant difference in the lives of patients.

Position Overview

The Quality Systems Technical Manager is tasked with overseeing the consistent application and administration of Quality Systems, including Documentation, Deviation Management, Corrective and Preventive Actions (CAPA), Change Control, Self-Inspection, and Risk Management.

Key Responsibilities:

  • Engage in preparation for inspections, support during regulatory inspections, and conduct self-inspection activities.
  • Analyze quality system metrics and trends.
  • Collaborate across departments with management to ensure uniform application of quality systems.
  • Contribute to initiatives aimed at enhancing quality systems and process mapping.
  • Draft and manage site-specific Quality Technical Agreements.

Educational Background:

  • Bachelor's or Master's degree, preferably in life sciences.

Certifications:

  • CAPA certification.

Essential Skills:

  • Expertise in Quality Systems Management.
  • Knowledge of Current Good Manufacturing Practices (cGMPs).

Additional Skills:

  • Proficiency in Change Control.
  • Understanding of Compliance and Regulatory requirements.
  • Experience with Internal Quality Audits.
  • Operational knowledge.
  • Risk Management expertise.

Professional Experience:

  • A minimum of 6 years of experience in the pharmaceutical industry or a related field.
  • Proven understanding of cGMPs, Health Authority Regulations, Quality Systems, and technical knowledge of manufacturing processes.
  • Ability to interpret technical information related to analytical methods, manufacturing processes, and regulatory expectations.
  • Familiarity with FDA, European, and international regulatory frameworks.

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