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Director/Sr Director Supplier Quality Management

Candel Therapeutics
9 hours ago
Full-time
Remote friendly (Needham, MA, United States)
United States
$258,000 - $280,000 USD yearly
Indeed

Director/Sr Director Supplier Quality Management Why Work With Us? Location: Hybrid (Needham, MA office) Salary: $258,000-$280,000 Candel is a clinical-stage biopharmaceutical company developing innovative multimodal viral immunotherapies designed to harness the power of the immune system against cancer. With positive Phase 3 results from our lead program and BLA readiness underway, Candel is reaching an important inflection point—one that creates the opportunity to translate scientific innovation into meaningful impact for patients, while the company continues to advance the next generation of programs across solid tumors. This is an exciting time for Candel as we evolve from a focused clinical-stage biotechnology company toward an integrated biopharmaceutical organization. Our people are at the heart of that journey! We believe breakthrough science is powered by people who challenge convention, bring different perspectives, collaborate across disciplines, and focus on shared outcomes. Candel’s culture is grounded in trust, flexibility, accountability, creativity, and a shared commitment to one goal: improving the lives of patients and their families. Role summary: This newly created role offers an opportunity to build and lead the Quality Supply Chain function in a growing biotech organization. Reporting directly to the SVP of Quality, you will own the Supplier Qualification Program and Quality oversight of supply chain activities supporting clinical trials and commercial supply. We are looking for a self-starter who takes ownership, follows through, and brings integrity to every detail. You will have the opportunity to develop programs, strengthen cross-functional partnerships, and create the structure needed to support Candel’s next stage of growth. Key priorities during the first year include executing Quality Supply Chain responsibilities in support of BLA, PAI, Commercial Launch, one Phase 2 clinical trial, and one Phase 3 clinical trial. What You’ll Own Supplier Quality and Supply Chain Oversight Provide strategic leadership for global Supplier Quality Management (SQM) program by establishing quality, safety, regulatory, and supplier governance strategies that ensure the reliable supply of raw materials, components, drug substance, and drug product, while protecting patients, and business continuity worldwide. Lead the development, deployment, and continuous improvement of global supplier quality systems, standards, and approval processes, including supplier qualification, risk assessment, audit programs, material approval, regulatory compliance, and supplier performance management to ensure consistent execution across all regions and business units. Drive supplier risk mitigation, resilience, and strategic partnership programs by leveraging risk-based decision making, supplier capability assessments, quality metrics, and cross-functional collaboration to strengthen supply continuity, accelerate innovation, and reduce supplier-related incidents Build and develop a high-performing global Supplier Quality organization by providing technical leadership, coaching, and organizational direction, while fostering strong partnerships with Analytical Development, Finance, MSAT, R&D, QC, supply chain and external suppliers to advance business goals and quality excellence Drive enterprise quality performance through data-driven supplier governance by establishing key performance indicators, monitoring supplier quality trends, identifying emerging risks, and leading corrective and preventive actions that deliver measurable improvements in supplier quality, compliance, and supplier reliability. Lead Supplier Quality Management program ensuring robust supplier quality systems, product safety and regulatory compliance, supplier risk management, raw material, component resiliency, packaging governance, and strategic supplier partnerships that enable reliable supply, innovation, and business growth globally. Mana…

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