Candel Therapeutics

Director/Sr Director Supplier Quality Management

Needham, MA
Full Time
Senior Manager/Supervisor

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.
  • 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.

 
Share

Apply for this position

Required*
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 07/31/2029
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*