Sr. Associate, Quality Compliance

-saving medication is done with the highest regard for quality and compliance to regulations.

Roles & Responsibilities:

As an integral team member working globally with BIDA, other R&D Quality team members, and R&D Quality stakeholders to ensure quality across our trials and compliance with GxP regulations and other requirements:

• Extract and clean data from internal systems for regular and ad hoc reporting, including data pipeline creation and maintenance

• Generate, validate, and deliver KPIs, quality metrics, and performance indicators used across the R&D Quality landscape

• Investigate and analyze metric trends, anomalies, and operational insights

• Design, build, and maintain Tableau dashboards for operational monitoring, compliance reporting, and executive summaries

• Develop and maintain Python scripts used for data processing, transformation, and report automation

• Help create reusable components for common data analysis tasks and documentation.

• Ensure version control and proper documentation of scripts and workflows.

Basic Qualifications and Experience:

• Master's degree and 7-10 years in Pharma and Biotechnology R&D Quality OR

• Bachelor's degree and 10-15 years of years in Pharma and Biotechnology R&D Quality.

Functional Skills:

Must-Have Skills:

• Exceptional attention to detail and accuracy in all deliverables.

• Ability to work independently and proactively in a fast-paced environment.

• Proficiency with Tableau or similar data visualization tools

• Familiarity with Python or other object-oriented programming language

• Familiarity with SQL and Databricks

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams)

• Effective communication, critical thinking and problem-solving

• Experience in conducting data analyses and translating data sets into actionable insights

Good-to-Have Skills:

• Familiarity with project management tools and methodologies

• Knowledge of GCP, GLP and/or GPvP

• Familiarity with Databricks and SQL

• Experience working in a multinational environment with global teams.

• Experience within Biotech/pharmaceutical Research

• Independent and teamwork capabilities

Soft Skills:

• Excellent verbal and written communication skills

• High degree of professionalism and interpersonal skills

• Strong problem-solving abilities and adaptability to changing priorities

• Collaborative mindset and ability to build positive relationships across diverse teams

• Resilience, discretion, and the ability to thrive under pressure

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