Quality Assurance and Compliance Expert

5 days ago

Dublin, Dublin City, Ireland Sia Full time
Regional Senior Manager - Quality and Compliance

Sia is a global management consulting group that was born digital in 1999. Our strategy and management capabilities are augmented by data science, enhanced by creativity, and driven by responsibility. We help clients initiate, navigate, and benefit from transformation. Our approach is based on optimism, which we believe is a force multiplier that helps clients mitigate downside and maximize opportunity. With expertise across a broad range of sectors and services, our consultants serve clients worldwide from multiple locations.

This position will be responsible for establishing and leading the EU Quality Assurance (QA) group within Latham BioPharm Group, Inc. The role will report to the US Director of Global Quality Services and will involve coordinating and leading all compliance activities, including Disposition, SOP writing, auditing, and SME for QA activities. As Latham operates globally, employees work remotely, and the role holder must be able to effectively operate in this model to achieve short-term and longer-term compliance and team goals.

The ideal candidate will have at least 15 years of experience in QA and compliance, with a focus on product development and regulatory affairs. They should possess a proven ability to lead and coordinate compliance activities through various stages of development. Strong management, organization, and leadership skills are essential, as well as the ability to take a risk-based approach to compliance across functions and manage a departmental budget.

The role requires excellent interpersonal relationship skills, flexibility to adapt to a fast-paced environment with changing priorities, and the ability to work independently. Responsibilities may include creating robust compliance strategies, maintaining quality management systems, ensuring documentation supports GXP compliance, conducting audits, performing due diligence assessments, building and managing the QA department, and reporting on compliance activities.

  • Create robust compliance strategies in each GXP area, working with vendors and internal/external stakeholders.
  • Maintain (and create where needed) SOPs and other documentation to support GXP compliance across all functions.
  • Ensure clients have appropriate documentation or other systems in place to maintain appropriate compliance in all functions.
  • Conduct, lead, or guide audits of internal and external parties as required for GXP compliance.
  • Perform due diligence assessments for external parties.
  • Build and manage the QA department at the EU location.
  • Assist clients in managing compliance.
  • Report on compliance activities, corrective actions to members of the client's Leadership Team as needed.
  • Chair quarterly Quality Meetings and generate minutes.
  • Support and coordinate with the US team's clients for overseas requirements and audits.

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