GxP Compliance Specialist

3 weeks ago


New York, New York, United States COMPASS Pathways Full time
This challenging role has become available at COMPASS Pathways for a GxP Compliance Specialist. As part of our Regulatory Affairs team, you will play a key role in ensuring the highest standards of quality and compliance across our operations. This critical position requires a strong individual with excellent communication skills, capable of prioritizing and managing multiple projects effectively.

Your responsibilities will include maintaining compliance within Compass policies and procedures, establishing necessary service offerings, and roadmapping budget for future capabilities. You will also take on the lead role in dealing with functional vendors/service providers, validation resources, and associated contracts. A high level of autonomy is expected in providing clear recommendations to key stakeholders based on thorough analysis and best practice.

To excel in this position, you will need a Bachelor's degree in IT, Engineering, Computer Science, or a related field, extensive experience in validation engineering within the biotechnology or pharmaceutical industry, and a proven track record of leading and managing IT projects and teams. In-depth knowledge of GxP compliance, GAMP 5, FDA regulations, and risk-based system life cycle management is essential. Strong problem-solving skills and the ability to adapt to changing priorities and deadlines are also required. Additionally, you will need excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

CORRECTED COMPASS Pathways offers a competitive salary range of $180,000-$220,000 per annum, plus additional discretionary bonuses and equity opportunities. Our comprehensive benefits package includes health insurance, retirement savings, and paid time off. We pride ourselves on being an equal opportunity employer, committed to diversity and inclusion in the workplace.

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