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Associate Manager, Quality Assurance - Validation job in Pennington at PTC Therapeutics

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Associate Manager, Quality Assurance - Validation at PTC Therapeutics

Associate Manager, Quality Assurance - Validation

PTC Therapeutics Pennington, NJ Full-Time
Job Description Summary:

The Associate Manager, Quality Assurance (QA) - Validation supports the on-going enhancement of the PTC total quality system by supporting and executing commissioning and qualification activities related to the Gene Therapy manufacturing and testing site.

She/He will execute commissioning and qualification activities in the GMP Gene Therapy Manufacturing Area, GMP Plasmid Manufacturing Area, the Quality Control (QC) laboratories, Microbiology, Raw Material, Sample and Stability areas, and GLP Bioanalytical Laboratories. This includes facilities, utilities, systems, equipment and instrument qualification/validation activities.

The incumbent is expected to function as a validation specialist. She/He will be required to execute validation projects, delivering validation projects that meet the quality requirements as well as adhering to project timelines.

She/He will work cross-functionally with internal departments (Analytical Development, Manufacturing, IT, EHS, etc.) and external resources (Vendors, Consultants, Contract Laboratories, etc.), both domestically and internationally, to support manufacturing and laboratory related issues.

She/He will support the realization of the site validation master plan, sub volumes, and project qualification plans. She/He will work closely with technical services to develop and maintain the re-qualification and equipment lifecycle program using quality risk management principles.

This position requires adherence to relevant regulatory requirements, the Quality Management System (QMS) and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:


* Performs validation activities related to various ongoing projects. This Includes, but may not be limited to:
* Authoring Validation and Project Qualification Plans.
* Authoring and overseeing system owner definition of User Requirement Specifications (URS), Design Specifications, Functional Specifications.
* Reviewing, developing, and executing Factory Acceptance Testing (FAT)/ Site Acceptance Testing (SAT)/Tech Transfer plans (as required).
* Facilitating the completion and documentation of Critical Aspect Risk Assessments and associated mitigating actions.
* Authors and executes commissioning and qualification protocols. Completes associated documentation.
* Designing and performing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols for Facilities, Utilities, Equipment, Instruments, and Systems.
* Creating and executing Addendum protocols ensuring 21 CFR Part 11 compliance.
* Documenting and resolving protocol deviations.
* Authoring final reports and compiling qualification documentation.
* Educating and training team members on principles of validation.
* Delivering on time completion of project deliverables

* Supports and completes the periodic review and re-qualification process for Facilities, Utilities, Systems, Equipment/Instruments.
* Performs temperature mapping of temperature-controlled units, classified areas, and materials storage areas.
* Prepares, reviews, and approves relevant Change Controls, Corrective Actions and Preventive Actions (CAPAs)s, and/or investigation reports.
* Proactively develops and maintains the technical skill set required to perform the functions of this role.
* Assists in the management and/or oversight of outside contractors for validation-related activities.
* Ensures validation systems supporting GMP manufacturing related activities align with corporate and departmental objectives and requirements and that they meet compliance standards as defined by the relevant regulations.
* Continually monitors and assesses changes in regulations/guidance's relative to the GMP and GLP validation program, appropriately communicates validation requirements on an on-going basis and ensures relevant changes are applied to validation systems as appropriate.
* Reviews, revises, approves, and harmonizes SOPs to ensure compliance with internal processes and regulatory requirements related to the validation program.
* Engages in quality system continuous improvement initiatives to enforce the quality culture.
* Performs other tasks and assignments as needed and specified by management.


* Bachelor's degree and 5 years of experience, or a Master's degree and 3 years, in a technical, scientific, engineering, or other relevant academic discipline and a minimum of 3 years of experience in GMP systems validation in a GMP regulated pharmaceutical, biotechnology or related environment.
* Demonstrated, and applied understanding of applicable GMP or other relevant regulatory authority regulations and guidance's related to system validation. This includes, but may not be limited to, GMP, GAMP, Part 11, Annex 11, ASTM and ICH Q9 activities and compliance.
* In-depth knowledge of relevant CFR (Title 21), Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) guidelines including thorough knowledge of appropriate GCP, GLP, and GMP policies and procedures.
* Demonstrated understanding of compendial requirements (USP, EP, JP) and Industry Guidance (e.g. ICH).
* Demonstrated ability to perform validation activities and communicate/escalate critical issues to appropriate management, as necessary.
* Demonstrated experience in evaluating legacy systems, performing gap analysis assessments, and developing gap analysis reports in accordance with regulatory requirements.
* Demonstrated and applied understanding of cGMP/GLP and GDP practices and EHS requirements.
* Ability to comply with all applicable SOPs, internal department requirements and external regulations.
* Proficiency with Microsoft Office and Project Management Tools.
* Excellent verbal and written communication skills including the ability to develop and deliver presentations and communicate cross-functionally.
* Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
* Analytical thinker with excellent problem-solving skills, attention to detail, and the ability to adapt to changing priorities and deadlines.
* Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
* Facility/laboratory start-up experience with a focus on equipment, utility, or computer system qualification/validation preferred.
* Proficiency with qualifying Utilities such as compressed gasses, water systems, HVAC, Building Automation Systems preferred.
* Demonstrated knowledge and experience in Temperature Mapping preferred.
* Biologics, small molecule, or gene therapy experience in a clinical and commercial manufacturing environment preferred.
* Experience using Maximo, Electronic Laboratory Notebook (ELN), and Laboratory Information Management Systems (LIMS) preferred.
* Travel requirements: 0-10%
* Office based position with on floor support in manufacturing, warehouse, and laboratory areas. Requires the ability to lift approximately 25 lbs. Requires the ability to gown into clean rooms and wear PPE. Requires light physical activity such as walking between buildings, transporting documents, standing for long periods of time.

At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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