Director/Sr Director Supplier Quality ManagementLocation: Hybrid (Needham, MA office)
Salary: $258,000-$280,000
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 OwnSupplier 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.
- Manage the end-to-end quality lifecycle of Candel Therapeutics' Supplier Qualification Program.
- Manage the Approved Supplier List and Annual Supplier Qualification Plan.
- Act as the primary Quality representative for Supply Chain projects and routine operations, including inventory management, shipping and receiving, and compliance/business risk mitigation.
- Provide Quality oversight of clinical trial product shipping and receiving to clinical sites across multiple trials.
- Perform routine internal audits of the Supply Chain function and participate in audits of the Supplier Qualification Program.
- Participate as an SME and Quality support during health agency and partner inspections and audits.
- Support review of regulatory submission source documentation and applicable submission sections related to the Supplier Qualification Program and Supply Chain activities.
- Lead and develop two direct reports (contract), setting priorities and coordinating execution of supplier quality and supply chain activities.
Required Qualifications- Bachelor's degree in a relevant Life Science, Engineering, or other technical discipline.
- Hands-on experience in a supply chain Quality role managing supply chain programs and audits.
- Minimum 10 years of experience with progressive responsibility in Quality Assurance required.
- Leadership/management experience with direct reports.
- Experience owning vendor qualification programs and vendor auditing.
- Experience with eQMS, EDMS, training systems, and other regulated platforms.
- Experience with enterprise resource planning (ERP) systems supporting supply chain operations.
- Demonstrated experience supporting clinical trial product shipping and recieving to clinical sites.
- Experience with FDA, EU, Global regulatory agency interactions and inspections.
- Working knowledge of applicable regulations, including 21 CFR Parts 210 and 211, 312, 314, 21 CFR Part 11, 600, 601, 610 and Eudralex Volume 4, ICH Q7,8,9, and 10.
- Demonstrated cross-functional collaboration and ability to influence without authority.
- Strong adaptability and project management skills.
- Ability to navigate ambiguity, prioritize competing needs, and independently advance work.
Preferred Qualifications- Professional certification in procurement discipline (i.e. CMRP, CSPC, PMP, CPM, and APICS) or Lean Six-Sigma process improvement experience.
- Familiarity with broader clinical and commercial supply workflows, including the ability to provide coverage for Quality peers.
- Experience working with contract development and manufacturing organizations (CDMOs).
NOTE: All applicants must be authorized to work in the U.S. and not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time.
