We are seeking an experienced GMP Compliance Leader to provide strategic and operational Quality Assurance support across pharmaceutical and biotechnology operations. This individual contributor role will partner with Quality Management, Quality Assurance, CMC, Supply Chain, and cross-functional teams to maintain regulatory compliance and drive quality improvements.
The ideal candidate will have strong experience in GMP compliance, quality investigations, CAPA management, batch disposition, change control, and audit coordination within a pharmaceutical or biotech environment
Position Details:
- Pay: $47/hr
- Duration: 6+ months (contract)
- Schedule: Monday-Friday, 8:00 AM-4:00 PM
- Location : Durham, NC 27709
Key Responsibilities
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Support and perform batch disposition activities and product quality complaint investigations.
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Lead and manage deviations, quality events, root cause investigations, and CAPA activities.
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Oversee and support change control processes and quality improvement initiatives.
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Lead, coordinate, and participate in GMP audits and regulatory inspections.
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Provide Quality Assurance support to CMC, manufacturing, and Supply Chain functions.
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Partner with internal stakeholders and external vendors to ensure ongoing GMP compliance.
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Identify quality risks, recommend mitigation strategies, and escalate significant compliance issues.
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Maintain accurate quality documentation in accordance with GMP regulations and internal SOPs.
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Support the implementation of Quality Management Plans and Risk Management Programs.
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Provide guidance on quality systems, regulatory requirements, and compliance best practices.
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Prepare quality reports, risk assessments, and updates for business stakeholders.
Required Qualifications
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Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or a related discipline.
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Strong experience in Quality Assurance, GMP compliance, or Quality Management within the pharmaceutical or biotechnology industry.
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Hands-on experience with deviations, investigations, CAPA, and change control.
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Experience supporting GMP audits and regulatory inspections.
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Knowledge of batch disposition, product quality, and pharmaceutical manufacturing processes.
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Understanding of CMC, pharmaceutical supply chain, and quality management systems.
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Knowledge of applicable regulatory requirements, ICH guidelines, GxP, and SOPs.
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Strong communication, analytical, problem-solving, and stakeholder management skills.
Preferred Qualifications
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Experience with Good Clinical Practice (GCP) and ICH guidelines.
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Experience working with pharmaceutical companies or Contract Research Organizations (CROs).
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Experience developing or implementing Quality Management Plans and Risk Management Programs.
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Ability to independently manage quality matters and collaborate with cross-functional teams.
