This is a 12-month initial contract with a strong view to extension.

Purpose Quality and Compliance Oversight of a contract lab, CMO or raw material SRE.

Alignment with CTA / Marketing Application.

Responsibilities Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.

Negotiator and Approver of quality agreements Lead the preparation of the site for and represent the company at product-speci?c Regulatory Inspections and/or during Noti?ed Body audits of CM Site, as applicable or required.

Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas Review / Approve Master Batch Records Quality approver for deviations, change controls, CAPA 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 APR Data Provider Manage Audit commitments to completion Perform tactical batch disposition activities in support of lot release Decision to release or Reject batches (Dynamic is different for SREs) Decision to approve or reject deviations, Change Control, CAPA Decision to approve QAGR Provide Quality position on GMP related topics and strategy for the site Decision to approve Master batch Records/Raw Material Specifications Requirements 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 - desirable not essential Significant Quality experience at Aseptic Manufacturing facilities Able to facilitate and influence senior stakeholders and partners Able to successfully manage workload and timelines Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Strong project management, problem-solving, and analytical skills Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving decision-making by using DAI principles Experience with the variation management process Skills: Quality Compliance Labs Biotech Industry Management