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 Sr GxP Auditor will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, procedures, and appropriate processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors.

 

Here Is What You Will Be Doing:

 

• Responsible for assuring the quality of clinical systems, processes and related activities.
• Ensures programs, including clinical trials, meet global regulatory and Passage Bio requirements. Manage and conduct both internal and external quality audits, while supporting a compliance culture and process improvement.
• Implement and maintain Passage Bio QA audit program to support aspects of pre-clinical to post-approval clinical programs. Lead qualification, routine and for-cause audits of external service providers, including CROs, investigator sites, non-clinical labs and documents, laboratory and data management vendors, and other vendors to assess effectiveness of their QMS and compliance to approved study protocols and contracts
• Conduct internal and external document reviews and audits, including regulatory application documentation, protocols, study reports, and Trial Master File documents.
• Act as the liaison for Clinical trial-related activities, including clinical meeting representation and review of clinical procedures and procedural documents.
• Assist with inspection readiness activities for third party audits of Passage Bio and external service providers, including regulatory authority inspections.
• Coordinates tracking of document requests and responses.

 

 

 

 

Here Is What You Will Bring To The Table:

 

• Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.).
• Minimum 5 years of GCP auditing experience of Early Phase and Late Phase clinical trials in the CRO and/ or Pharma industries required
• Experience hosting sponsor audits & regulatory inspections highly preferred
• Experience with gene or cell therapy auditing programs
• Direct CRO or Pharma experience preferred in GCP auditing
• Knowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferred
• Ability to execute strategy and plans
• High degree of flexibility and ability to adjust to changing priorities and unforeseen events
• Travel up to 50% 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.