Senior Quality Auditor

Passage Bio is an exciting, fast-paced gene therapy company headquartered in Philadelphia, PA. Our portfolio of 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 CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.

The Role:

The Senior Quality Auditor will perform GxP audits of pharmaceutical manufacturing, packaging/ labeling, laboratory controls, technical services, storage & distribution and quality systems for sterile/non-sterile APIs, plasmid/vector manufacturing, drug products, medical devices, combination products, packaging materials and services.

Here is What You Will Be Doing:

Schedule, prepare, conduct, document, and follow-up of assigned GxP audits in accordance with Passage Bio’s corporate standards.
Initial assessment of audit deficiencies, corrective and preventive actions, and overall vendor/site compliance status based on regulatory GMP requirements and specific Passage Bio requirements.
Communication to stakeholders on potential risk and product impact from observations and GMP deficiencies found during audits.
Provide support with supplier qualification issues and supplier risk assessment based on audit result when required/requested.
Support notification to management process in case of critical audit findings in collaboration with audit regional lead and audit plan owner.
Train other auditors, as needed.
Maintain audit related records, track and trend audit observations/Metrices.
Support eQMS implementation.
Regular participation in GMP trainings (internal/external).

Here Is What You Will Bring To The Table:

Bachelor’s degree in applicable discipline or equivalent experience.
Minimum 3 years experiencing auditing gene or cell therapy manufacturing programs-preferred.
Minimum 10 years of experience required as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 75 audits performed in a Lead Auditor role or have a Lead Assessor certification from an accredited agency.
Ability to write concise and comprehensive audit reports.
Ability to give presentations, as needed.
Must be able to travel approximately 75% --both domestic and international.

Here Is 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
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)

Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination required.

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.

Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled