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 Director of GxP Applications and Systems is responsible for defining key processes and requirements; designing, planning, implementing, and evaluating IT systems which supports clinical development and regulatory approval of products. Director of GxP is a leadership role responsible for defining, implementing, maintaining, and overseeing the strategy, plan and execution for IT CSV/CSA regarding adherence to applicable global regulatory requirements (i.e. 21 CFR Part 11, Annex 11) with the objective of managing business risks appropriately. This role requires extensive interaction working with business colleagues to align technology direction with business goals,  a thorough knowledge of validated applications, and the ability to work with both in-house design and managed services.

 

Here Is What You Will Be Doing:

 

·        IT system owner responsible for selection, development, validation, maintenance, and continuous improvement of corporate clinical GxP information systems, including QMS (Qualio), LMS. Sharepoint, eTMF, CTMS, eCTD, and Pharmacovigilance.

·        Direct the analysis, design, development, and installation of corporate GxP applications in accordance with established IT and Quality policies and procedures. Provide technical consultation and implementation of new corporate clinical GxP information systems to support the organization as needed.

·        Project manage technology implementations, including coordination and management of external vendors and ensuring adherence to GxP SOPs. Review vendor generated validation documentation to determine suitability and alignment with company CSV SOPs. Determine the appropriate level of qualification and validation necessary for computing systems to ensure holistic risk management, balancing regulatory and compliance needs with business risks.

·        Partner, collaborate and align with business colleagues to define and document critical business processes and requirements, prioritize requests, create business cases for technology solutions, and manage them through the IT governance process.

·        Oversee application lifecycles for business partners including Quality, Clinical, Regulatory and Safety systems in use including change control, testing, validation, and communication.

·        Create and update technology roadmaps, aligning technology path with business drivers and timing.

·        Lead or support deviation/incident investigations related to corporate GxP information systems and manage the implementation of identified Corrective Actions / Preventive Actions (CAPA) resulting from these investigations. Maintain expertise in current and emerging requirements, quality trends and IT technology trends that can impact CSV/CSA.

·        Partner with QA to manage system validation, change management, periodic reviews and vendor assessment/qualification. Monitor audit observations related to GxP computerized system and computer system validation to ensure gaps are identified and adequately addressed,

·        Assist as needed in external/internal audits and inspections. Act as subject matter expert for CSV/CSA during regulatory inspections.

·        Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, and integration.

·        Support the organization with validation of and enhancements to Sharepoint.

 

 

 

Here Is What You Will Bring To The Table:

 

·        Degree in information systems or an equivalent combination of relevant education and job experience

·        Minimum of 10 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry. 

·        Thorough understanding of the principles of computer systems validation, IT GxP, risk-based approach, and testing best practice.

·        Ability to understand existing and new business processes and requirements, to ensure proper implementation and validation of systems.

·        Solid skills defining and documenting business processes and requirements

·        Prior experience with Quality Management Systems, including Clinical, Quality, Regulatory and Safety.

·        Strong skills and experience project managing implementations of packaged applications using a system development life cycle (SDLC)

·        Demonstrated experience documenting requirements for data exchange and managing the implementation of data flow between systems and into data warehouses

·        Adept at driving business-focused conversations regarding metrics, capabilities, and opportunities for innovation

·        Outstanding communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management

·        A proven track record in delivering change and transformation projects and their associated benefits to an agreed time-line, budget and quality

·        Previous experience in writing, reviewing, and executing computer validation documentation including but not limited to Risk Evaluation, Risk Assessment, VMP, IQ, OQ, PQ, TM

·        Previous experience with designing and implementing Microsoft Sharepoint in a validated environment.

 

Position Location and/or Territory and Travel 

• Home office is located in Philadelphia, PA.  Position can be remote but scheduled travel will be required and the ability for immediate audit travel is necessary.

 

 

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.