GMP Supplier Quality Auditor

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform - Encapsulated Cell Technology (ECT) platform is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel) For over two decades, we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform, designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, leveraging ECT's innovative approach to provide sustained, targeted treatment directly to the eye. 

Neurotech is seeking a Supplier Quality Auditor to work with suppliers and act as the liaison between the site and Global Quality team to ensure suppliers/vendors continue to deliver quality products and services to the company. This responsibility will be realized through the participation in the Supplier Quality Management (SQM) team, performing supplier/vendor audits, maintaining the supplier corrective action program managing the site’s Quality Agreement portfolio, and interaction with the individual supplier/vendor as appropriate.

This position is located in Cumberland, Rhode Island. This is not a remote or hybrid opportunity.

Please note, this role is not eligible for agency recruiting support. Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Essential Functions and Duties  

• Plan, perform and oversee the auditing process and responses that includes timely completion of audits and quality agreements in the Quality Management System.
• Document supplier audit and write audit reports that are distributed and reviewed by appropriate management.
• Assures that the Quality System audit function complies with GMP, ISO, and all applicable regulatory requirements.
• Review and evaluate audit responses against current standards, regulations, and guidelines to ensure compliance.
• Track and trend supplier responses and prepare metrics for management review.  
• Drive on time closure of corrective and preventative actions to ensure implementation, compliance, and continuing efficacy.
• Assist in maintaining the Supplier Qualification Program for existing and new suppliers/vendors, including maintaining and revising quality agreements as required.
• Manage professional relationships with suppliers to ensure their adherence to quality standards and facilitate environment of continual improvement.
• Capable of Project Management exercises to implement SQM projects, initiatives, and improvements either as an individual contributor or as part of a team.
• Ability to work with cross functional teams including Manufacturing Operations, QA Management, Supply Chain, and Service Providers to provide advice and support in the resolution of compliance related concerns and initiatives and apply their own professional knowledge and experience to proactively identify areas of risk to compliance GMPs.

Qualifications 

Education and Experience 

• BA in Science disciplines
• Minimum four (4) years of pharmaceutical industry experience
• Minimum 3-5 years of auditing experience preferred.

Knowledge, Skills, and Abilities  

• Extensive SQM experience
• Auditor Qualifications ASQ-CQA is a plus.
• Proven ability to conduct and manage audits.
• Strong knowledge of quality and compliance in regulated GxP/QMS environment
• Handling Audits, Approved Supplier List (ASL), Quality Agreements.  
• Very good communicator, writing, time management, and organizational skills
• Ability to travel and work remotely across functions.
• Ability to work autonomously and multi-task.
• Adaptable to change and fast paced environment.
• Ability to draw on past experiences to influence future outcomes.
• Ability to research information for problem resolutions for projects and position roadblocks 

LICENSES/CERTIFICATIONS: 

• Certification as an auditor by an organization recognized within the pharmaceutical industry desired.

PHYSICAL DEMANDS:  

• Manual dexterity required to operate office equipment.
• Carrying, handling, and reaching for objects
• Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS: 

• Willingness to travel to various vendor sites, local and national, including overnight trips. Some international travel may be required in the future.
• Travel will vary based on resourcing.  Initially 25-30%.  Could be less as the team is resourced appropriately.  

Applications are currently being accepted through the Neurotech Career Center.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.