Job Description
Proclinical is seeking a Director / Senior Director, GCP Quality Assurance for a leading biotech company located in Cambridge, MA (Northeast). This individual will partner with your clinical and nonclinical development colleagues to oversee a network of contract vendors while simultaneously building GCP/GVP/GLP processes and standards to support our pipeline and future growth.
Must be eligible to work or be a citizen in the US.
Job Responsibility:
- Provide expertise in GCP, GVP and GLP compliance interpretation, consultation, training, and recommendations to clinical and nonclinical development functions and program teams.
- Develop standards and practices to support clinical and nonclinical project teams and oversee a network of vendors providing regulated services.
- You will ensure that clinical and nonclinical programs have adequate Quality support and work with Head of QA to ensure adequate planning and budgeting.
- You will conduct risk assessments and identify areas and vendors to be audited and identify process improvements for all work involving GCP/GVP/GLP.
- You will plan/conduct/oversee GCP/GVP/GLP internal audits and provide audit metrics, audit observations, and develop robust CAPAs for cross functional team and management review.
- You will provide GCP/GVP/GLP subject matter expertise related to inspection readiness preparation and provide SME support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions.
- You will lead, interpret, and manage quality investigations associated with GCP/GVP/GLP operations.
- You will be flexible and adaptable. You will collaborate with your Quality Management Systems colleagues and ensure systems work fluidly to ensure GXP compliance.
- You will define, analyze, report, and present metrics to functional teams and Quality management; recommend any required actions and monitor implementation.
- You will provide review of applicable GCP/GCLP/GVP documentation and regulatory submissions.
Skills and Requirements:
- You have a keen attention to detail but can stay focused on the big picture of continual improvement.
- You are a team-player, flexible and easy to work with in a fast and collaborative environment. You are solution oriented with a customer service approach.
- You are willing to "roll up your sleeves" and engage in all aspects of the role, big and small.
- You have great communication skills and enjoy building relationships being a Quality ambassador both internally and at our vendors
- Bachelor's degree in a scientific field.
- Minimum of 10+ years of Quality Assurance/GCP/GCLP/GVP Operations experience in pharmaceutical or biotech industry.
- Extensive experience in building GCP, GVP and GLP systems and processes and have participated in building a GCP QA function.
- Experience in implementing GLP/GCP/GVP inspection readiness program, including mock inspection activities.
- In-depth knowledge of GCP/GCLP/GVP and QA principles, practices, and standards; thorough understanding of FDA, MHRA, EMA and ICH quality regulations.
- Experience implementing risk management as per ICH E6 R2 into clinical practices and procedures.
If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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