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?
À±½·ÊÓƵ 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 a.maldonado@proclinical.com
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.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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