Senior Specialist, Quality Assurance - Validation at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

The Senior Specialist, Quality Assurance (QA) – Validation supports the on-going enhancement of the PTC total quality system by leading and providing QA oversight of commissioning and qualification activities related to the Gene Therapy manufacturing site.

The Senior Specialist will primarily support the commissioning and qualification of the Quality Control (QC) laboratories, Microbiology, Raw Material, and the Sample and Stability areas. This includes equipment and instrument qualification/validation and methods qualification activities. The Senior Specialist will also support manufacturing as needed.

The Senior Specialist will work cross-functionally with internal departments (Analytical Development, Manufacturing, IT, etc.) and external resources (Vendors, Consultants, Contract Laboratories, etc.), both domestically and internationally, to support facility and Laboratory related issues.

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

Job Description:

Responsibilities:

• Writes, reviews and/or executes and approves commissioning and qualification documentation. Including, but may not be limited to: Validation Plans, Functional Risk Assessments, User Requirement Specifications (URS), Installation, Operational and Performance Qualification (IOPQ) protocols, traceability matrices, and final reports for equipment/facilities, computer systems, cleaning validation, analytical laboratory instruments, and process validation.
  • This position will be highly focused on qualification for start-up of the manufacturing facility and ongoing requalification activities.
  
  


• Identify, document, and investigate protocol deviations in conjunction with cross functional teams, as required to resolve and close out deviations.


• Prepare, review, approve relevant change controls, Corrective and Preventative Actions (CAPAs), and/or investigation reports after validation activities.


• Proactive in developing the technical skill set through training, coaching, with the goal of professional growth, and improved job performance.


• Ensures validation systems supporting GxP manufacturing related activities align with corporate/departmental objectives and requirements and that they meet compliance standards as defined by the relevant regulations.


• Assist in the management and/or oversight of outside contractors for validation-related activities.


• Assists and/or performs quality reviews, internal audits, and QA vendor audits (as required).


• Continually monitors and assesses changes in regulations/guidance’s relative to the GxP manufacturing validation program, appropriately communicates validation requirements on an on-going basis and ensures relevant changes are applied to validation systems as appropriate.


• Review, revise, approve, and harmonize SOPs to ensure compliance with internal processes and regulatory requirements related to the validation program.


• Work with the Facilities and Manufacturing groups to review designs, develop and execute FAT/SAT/Tech Transfer plans (as required).


• Support regulatory inspections by FDA, EMA, and foreign regulatory agencies (as required).


• Engage in quality system continuous improvement initiatives to enforce the quality culture.  


• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor’s degree in technical, scientific, or other relevant academic discipline and a minimum of 5 years of experience in a GxP regulated pharmaceutical, biotechnology or related environment.  Must have minimum of 3 years of experience in GxP Systems validation, with a quality background preferred.


• Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance’s related to system validation (such as, GMP, GAMP, Part 11, Annex 11, ASTM, ICH Q9, etc.) 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.


• Knowledge and demonstrated understanding of compendial requirements (USP, EP, JP) and Industry Guidance (e.g. ICH).


• Demonstrated ability to lead and perform validation activities and ability to 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 and utility qualification preferred.


• Biologics, small molecule, or gene therapy experience in a clinical and commercial manufacturing environment preferred.


• Experience using, Veeva, Maximo, Electronic Laboratory Notebook (ELN), and Laboratory Information Systems (LIMS) preferred.


• Five (5) years of experience in GxP environment, with a validation background preferred.


• Personal skills and traits include: attention to detail, sense of urgency, team player, able to multi task, effective time management, able to effectively prioritize, good interpersonal skills, and lead by example preferred.


• Prefer one the following professional certifications Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred.


• Experience in clinical and commercial manufacturing environment preferred.


• Travel requirements: 0-10%


• Office/Laboratory-based 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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