Quality Manager

  • Norma intreaga
  • Data publicarii: 21-12-2021
  • Aplica inainte de: 30-01-2022
Job Detail
  • Nivel cariera Manager
  • Experienta 5 Ani
  • Sector Management
  • Nivel de studii Diploma de Licenta
Descrierea Jobului

Company’s mission is to do their part in getting lifesaving products and services to market fast by keeping healthcare honest. This company was founded by a team who have been at the forefront of Life Sciences software for almost 20 years. They have helped over 250 companies transform how they research, manufacture, and monitor the safety of their therapies. Combining automation with deep regulatory expertise, this software ensures the technologies used to bring new products to market meet the requirements of the FDA and global health authorities.

We’re looking for an experienced Quality Manager with quality and compliance expertise in SaaS products.

As a Quality Manager, you will provide direction for the validation, implementation, and administration of quality applications. You will partner with operations and product engineering teams to define company’s validation scope and strategy for general releases. The right candidate will possess a deep technical and regulatory understanding of cloud-based systems and their applications in GxP environments.

Responsibilities:

  • Provide quality assurance oversight, guidance, support, and interpretation on software validation activities to ensure regulations, protocols, policies, and methodologies are followed;
  • Serve as a system owner for quality systems and proactively initiates change controls when necessary;
  • Support business initiatives (computer software assurance, integrations) to ensure consistency with corporate regulatory standards and requirements across multiple channels and platforms;
  • Contribute to building a coherent strategy, vision and roadmap for quality programs;
  • Contribute to establishing quality goals and work with senior management to drive interdepartmental alignment;
  • Compile and assess quality metrics to enable a data-driven framework and build the strategy for improving quality initiatives;
  • Collaborate effectively in a dynamic, multi-regional, cross-functional matrix environment.

Requirements:

  • 5+ years of working in the regulated life sciences industry, SaaS, enterprise, or related functional roles specific to Computerized System Validation;
  • Proficient on GAMP 5, FDA and EU regulations;
  • Possesses direct management experience or aspirations;
  • Fluent in English, both written and verbal.

Benefits:

  • 100% remote working;
  • Competitive Compensation;
  • Private Healthcare Coverage;
  • Generous equipment budget;
  • Knowledge and Skills Grant.