Job Title: Quality and Compliance Oversight Specialist
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This is a 12-month initial contract with a strong view to extension, providing an opportunity to develop and grow within the company.
The purpose of this role is to oversee quality and compliance in a contract lab, CMO or raw material SRE environment, aligning with CTA/Marketing Application requirements.
Key Responsibilities:
* As a quality member of a cross-functional contract manufacturing team, negotiate and approve quality agreements.
* Lead the preparation of the site for and represent the company at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
* Present on topics during inspection, demonstrating appropriate behaviors and knowledge of subject areas.
* Review and approve Master Batch Records, Quality approver for deviations, change controls, CAPA, and prepare inspection playbooks.
* Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management.
* Perform Person in Plant activities as required, manage audit commitments to completion, and perform tactical batch disposition activities in support of lot release.
* Make decisions regarding batch release or rejection, deviation approvals, change control, CAPA, and QAGR.
* Provide Quality position on GMP-related topics and strategy for the site, and make decisions regarding Master Batch Records/Raw Material Specifications Requirements.
Requirements:
* A Doctorate degree & 2 years of directly related experience OR Masters degree & 4 years of directly related experience OR Bachelors degree & 6 years of directly related experience OR Associates degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience.
* Preferred Requirements: 10+ years biotech or pharmaceutical industry experience, additional European Languages, significant Quality experience at Aseptic Manufacturing facilities, ability to facilitate and influence senior stakeholders and partners, and strong project management, problem-solving, and analytical skills.
Skills: Quality Compliance Labs Biotech Industry Management
Estimated Salary Range: $120,000 - $180,000 per year