USA - Quality Compliance Specialist

Quality Compliance Specialist - Contract - Cambridge MA

Are you passionate about ensuring the highest standards in pharmaceutical quality and compliance, and ready to play a key role in safeguarding patient safety and product integrity?

Proclinical is seeking a Quality Compliance Specialist to provide quality oversight for clinical trial delivery systems.

Primary Responsibilities:

This position is required to ensure compliance with applicable regulations and promoting operational excellence. This role involves implementing monitoring systems, managing risks, and driving continuous improvement. You will act as a strategic partner in developing and executing GCP compliance strategies while fostering collaboration across various functions.

Skills & Requirements:

• Degree in a scientific, medical field or equivalent.
• Strong background in pharmaceutical development, clinical operations, or data management, with expertise in GCP compliance.
• Advanced knowledge of global GCP/GVP regulations (e.g., FDA, EU, MHRA, PMDA, ICH).
• Proven experience in audit program development, regulatory inspections, and remediation activities.
• Ability to manage complex compliance issues and implement organization-wide initiatives.
• Skilled in leading global, cross-functional projects.
• Excellent communication skills, with fluency in English; additional languages are a plus.

The Quality Compliance Specialist's responsibilities will be:

• Lead the clinical trial delivery system inspection readiness program, including strategic planning and stakeholder engagement.
• Provide insights on emerging regulations, compliance metrics, and inspection risks, offering strategic mitigation plans.
• Host GCP inspections and guide relevant teams and subject matter experts.
• Develop and execute communication plans for sharing inspection insights, risks, and progress updates.
• Manage inspection response activities, ensuring timely and thorough responses, root cause analysis, and CAPA development.
• Oversee the completion and closure of inspection CAPAs, ensuring effectiveness checks are in place and risks are mitigated.
• Act as a Subject Matter Expert (SME) on Clinical Quality Compliance activities, including deviation management, quality investigations, and CAPA oversight.
• Support non-GCP-specific inspections (e.g., GVP, GMP) as needed.
• Lead complex quality investigations and cross-functional improvement projects impacting clinical trial delivery systems.
• Promote knowledge sharing through lessons learned from inspections and investigations.
• Review and approve controlled procedures related to clinical trial delivery quality systems.
• Escalate critical compliance issues and analyze trends to maintain a state of compliance.
• Develop and monitor relevant metrics and Key Performance Indicators (KPIs) to assess the health of clinical trial delivery quality systems.

Compensation:

• $220,000 to $250,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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