Passage Bio is an exciting, fast-paced, rapidly growing gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.

 

The Role:

 

The Senior Auditor of Supply Chain is to provide external auditing of supplier manufacturers, laboratory and other service providers to ensure compliance to procedures, FDA and other regulatory requirements.

 

Here Is What You Will Be Doing:

 

 

  • Responsible for quality oversight for material suppliers and vendors for Passage Bio products in accordance with contracts, policies, standards, procedures and international regulations.
  • Provides required supply chain information to Qualified Persons and as needed for regulatory purposes.  Responsible for the risk assessment, approval, and audit activities related to various external service providers including, as required, raw material suppliers, ancillary material providers, labelling, packaging, and transportation suppliers.
  • Provides quality support to internal and external personnel, reviewing/ approving product related GMP documents, and authoring supplier-related quality system documents.
  • Works with internal stakeholders to provide appropriate metrics and the overall assessment of supplier compliance and performance.
  • Assists with inspection readiness activities for third party audits of Passage Bio and external service providers, including regulatory authority inspections, and coordinates tracking of document requests and responses.

 

 

 

Here Is What You Will Bring To The Table:

 

  • Bachelor’s degree or equivalent experience
  • Minimum 5 years quality systems auditing experience in the pharmaceutical, biotech, or medical device industry,with a focus us supply chain and supply vendors.
  • Preferred experience with gene or cell therapy manufacturing supply chain programs
  • Experience with auditing raw materials and components as well as analytical and micro laboratories.
  • Experience in Quality Assurance, including the ability to identify and resolve compliance issues.
  • Proven ability to identify, collaborate, and resolve supplier related compliance issues.
  • In-depth knowledge and understanding of cGMPs, GCPs, and Data Integrity principles.
  • Knowledge of EU regulations is preferred.
  • Computer proficiency including MS Office and SharePoint.
  • Travel up to 30% domestically and internationally.

 

 

Here’s What We’ll Bring To The Table

·        Up to $270 for public transportation and parking

·        Highly competitive healthcare coverage including: medical offered (HMO/PPO), dental, and vision offered

·        Summer hours from May to September with 1pm office closure*

·        Flexible Spending Accounts for medical expenses and dependent care expenses

·        12 weeks of 100% paid parental leave for all new parents within 6 month

·        401k (traditional and Roth offered) with 5% match

·        A suite of Passage Bio paid insurance coverage, including: life insurance, short-term and long-term disability

·        Voluntary legal assistance as well as pet, liability, critical illness, hospital indemnity and accident assistance

·        20 days’ vacation and Unlimited sick time per year, and 14 company paid holidays (includes 2 floating holidays in addition to a discretionary winter shut down)

 

Passage Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Passage Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

 

 

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