Who We Are:

PathoQuest is a specialized CRO, a spin-off of Institut Pasteur, whose purpose is to study, research and identify pathogens by High Throughput Sequencing for the Quality Control of pharmaceutical products of biological origin, both in France and abroad. PathoQuest offers innovative biotech companies worldwide a complete expert service from sample receipt to the production of certificates of analysis. Its tests are based on proprietary sample processing protocols, a high-throughput sequencing platform and specialised bioinformatics analysis pipelines. Currently in a scale-up phase, we have about 50 employees in France and the United States.

Your Role:

Reporting directly to the Chief Pharmaceutical Officer, your expertise will enable you to support our rapid growth in the testing of biological products. Your mission is to set up and maintain a quality system in connection with all the company’s activities to ensure that the activities comply with the required standards. You will also be in charge of the pharmaceutical responsibility in back-up of the Pharmacist in charge (Interim Pharmacist in charge).

Your responsibilities:

• Implement the quality assurance policy
• Prepare and lead customer audits
• Organize, plan and implement internal and subcontractor quality audits in order to ensure the application of current regulations, GMP on the site
• Train internal auditors
• Define and monitor annual internal and external audit plans
• Monitor the management and approval of suppliers and subcontractors according to their criticality
• Contribute to the preparation of management reviews
• Implement the business continuity plan
• Set up and maintain indicators for monitoring the quality of services provided
• Suggest improvements and/or developments in the field of quality
• Organize the Quality Management System and its compliance,
• Ensure the proper management of documentation
• To follow in particular the CAPA and to sensitize the personnel on this follow-up,
• Raise awareness and inform the company about the quality approach
• Develop quality assurance tools

Your profile:

• Pharmacist, you have 5 years experience in system quality assurance & compliance / supplier quality assurance,
• You are eligible for registration in section B,
• You have experience with biological products or in the field of biotechnology or quality control,
• As the position is cross-functional between Paris and the United States and in order to interact with the auditors, you have a fluent level of English
• You are familiar with GMP standards
• You have experience in operational QA (optional)

Your expertise:

• You like innovation and you want to participate in the development of a company
• Ability to lead cross-functional projects
• Leading multidisciplinary teams
• Ability to lead change
• Pragmatism, discernment, assertiveness
• Methodical, rigorous and autonomous

This position is based in Paris 13, the contract is open-ended. If you want to work in a dynamic and innovative start-up with great ambitions, please send your application (CV and cover letter) to careers@pathoquest.com

Who We Are:

PathoQuest (PTQ), a spin out of Institut Pasteur, offers innovative Next Generation Sequencing (NGS) based solutions for the Quality Control of biologics and the diagnosis of infectious diseases. The company’s Biologics Genomic Service focuses on providing Quality Control testing to biotech and biopharma companies for the rapidly growing areas of cell and gene therapies and viral safety testing for vaccines. PathoQuest is at the forefront of providing NGS-based testing solutions which will replace current standardized in vivo and in vitro testing options because NGS is faster, more robust and does not require the use of animals.

Based in Paris, France, PathoQuest has established a U.S. subsidiary and is expanding its capabilities by implementing a state-of-the-art testing facility at its location near Philadelphia.

The company also has a strong strategic partnership with Charles River Laboratories (CRL), a leading provider of preclinical and clinical laboratory services for the pharmaceutical, medical device, and biotechnology industries.

PathoQuest, is looking to hire a QA Manager for their US based office, Wayne, Pennsylvania

Missions and responsibilities

As the Head of QA for the US facility, your activities will define, drive, and support the quality and compliance systems for the US facility. You will be responsible for understanding, evaluating, and applying relevant regulatory compliance and QA standards for PathoQuest’s US operations. This role is to ensure the compliance needs of both the facility and clients are appropriately met, effectively interpreted, and communicated clearly to all relevant stakeholders.

The primary responsibilities for this position are:

• Define and implement our QA and compliance policies and standards in collaboration with our Chief Pharmaceutical Officer (CPO) and the global QA department.
• Primary liaison for internal/ external stakeholders, ensure current and emerging standards/ guidance are met or exceeded.
• Lead by example and work collaboratively to advance the application of NGS in a regulated context in the field of biosafety testing.

The ideal candidate will:

• Function as the site head for QA and regulatory compliance as they apply to PTQ.
• Organize, plan and report on US GMP site’s milestone, and readiness for GMP.
• Develop, manage, and provide training for Quality Specialists.
• Organize all quality, regulatory, operational, system and compliance activities including Regulatory filing for the US site.
• Identify, arrange, communicate the appropriate quality standards and requirements, as appropriate.
• Manage interactions with global regulatory agencies.
• Support the implementation, adaptation, and management of PTQ’s quality system across the organization.   
• Oversight for quality documentation such as SOPs, lab records (raw data, batch records, protocols, production records, study documentation, certificates of analysis, technical specifications, etc.), deviation records, vendor qualification forms, and other corporate documents to ensure full compliance with current regulations 
• Lead and oversee efforts associated with the installation, operational performance, validation/calibration, and performance qualification of lab equipment.
• Monitor and manage the company’s lab control systems
• Drive and support PTQ’s deviation, investigation, and CAPA processes including implementing out of specification (OOS) and out of trend (OOT) investigations, as needed.
• Manage, and track KPIs quality metrics 
• Define/deploy validation protocols for computerized lab and environmental monitoring systems per FDA’s 21 CFR Part 11 and the European Union’s Annex 11 
• Lead the US deployment of ongoing implementation of quality control training programs 
• Ensure staff are trained in current regulatory requirements to execute tasks and supporting activities within a regulated environment 
• Oversee and support the review and in-process audit of study and analysis files and data
• Liaison for management and support teams (program management) to ensure customer satisfaction
• Maintain appropriate professional certifications, training, and technical knowledge pertinent to job function and responsibilities. 
• Conduct audits (study/client/vendor/supplier/subcontractor) to ensure testing is performed in accordance with all SOPs, current regulations (cGMP) and local practicesto ensure PathoQuest US site is qualified by our clients,
• Conduct laboratory/facility inspections as per regulations and corporate policy
• Contribute to supplier/subcontractor qualification process and policies
• Organize a program of annual self-inspection
• Lead by example to ensure scientific and operational integrity
• Promote a culture of continuous improvement; act as champion on initiatives and/or projects to drive improvement in quality and/or client service.
• Manage PathoQuest’s Quality Manual and Master Files
• Act as a regulatory and quality consultant for our development, commercial operations teams and for client discussion.
• Evaluate new regulatory guidance and revisions to existing guidance to ensure the PTQ is compliant
• Understand and provide guidance to corporate business on needs and strategy
• Participate in consortia, conferences, and other forums to promote PTQ’s activities
• Lead and/or provide support for projects that cross multiple disciplines
• Provide leadership and direction, offer coaching and mentoring to other staff members (training, regulatory support for ongoing projects)
• Consistently demonstrate good communication and interpersonal skills
• Ensure group delivers a high level of client satisfaction and has all the necessary tools to execute each project
• Conduct reviews and one-on-one discussions as needed with direct reports
• Contribute to cross-functional activities and projects
• May perform other related duties as required and/or assigned

Qualifications and skills

Education

• PharmD/PhD with of minimum of 5 years, or Masters with 10+ years in Regulatory Affairs or a related discipline (quality, compliance, ) preferably with a QA or Quality Excellence group within a GxP environment

Experience

• Strong working knowledge of FDA (21 CFR Parts 11, 58, 210, 211, ) and international regulations (EMA, MHRA, ICHQ10 and ICHQ9, OECD requirements)
• Experience associated with the analysis of data, deviation review, and change control
• Active participation in regulatory, vendor or internal audits
• Leading, supervising, coaching, and training of staff in quality requirementsin a commercial laboratory setting

Required skills and qualifications:

• Excellent oral and written communication skills; Proficiency in French is desired, but not required
• Intermediate/advanced technical skills in applicable computer programs/tools,
• Collaboration, responsiveness, autonomy, ease of adaptation and flexibility are highly desired
• Excellent time management skills
• Broad working knowledge of laboratory policies and practices, as well as corporate goals
• Effective coaching and training (or supervisory where relevant) skills for complex and highly technical work
• Ability to interact within various cultural environments.
• Candidates must be eligible to work in the United States.

Our Current Benefits: 

We are in the process of reviewing and enhancing our benefits package and currently we are offering the following benefits:

Paid Time Off (PTO)

• In your first year, you will be eligible to accrue 10 days or 80 hours of PTO.
• After your 1-year Anniversary, you will accrue 15 days or 120 hours of PTO annually.

FLOATING HOLIDAYS (FH)

• You will be able to accrue up to 4 Floating Holidays depending on your date of hire. Floating Holidays represent holidays PathoQuest is open for business. You will have the opportunity to take the holiday or come to work and take the FH any time after the holiday.

HOLIDAYS

• For Year 2023 we will celebrate 8 holidays and they are:
  • New Year’s DAY
  • Memorial Day
  • Independence Day
  • Labor Day
  • Thanksgiving Day
  • Day after Thanksgiving
  • Christmas EVE
  • Christmas DAY
  • New Year’s EVE

 HEALTH, BENEFITS & SUPPLEMENTAL INSURANCE

• 100% Company Paid for Employee’s Medical, Dental & Vision, Basic Life Insurance & AD&D, Short- & Long-Term Disability coverage
  1. Dependent coverage is available at employee’s cost for Medical
  2. For 2023, 100% Company Paid for Dependent’s Dental & Vision coverage
• Additional Ancillary Insurance is available for Employee to purchase at group discounted rate
• All benefits start on Employee’s first day of employment.

COMPANY SPONSORED 401K RETIREMENT SAVINGS PLAN

• 401K Retirement Savings Plan with dollar for dollar match up to 6 percent of salary deferrals
• 100% Vesting into 401k Employer Matching Contributions on Day 1 of participation into the plan

Next Steps

If you are interested in joining our team, please submit your resume and expected compensation benefit package. A cover letter would be nice, but not necessary to careers@pathoquest.com. We will review and respond ONLY to those candidates who meet the qualifications and experience of the position along with compensation benefit required.