RETAINED SEARCH: U.S. Quality Assurance Leader (Top U.S. QA. role); Start-up US Group for EU Innovative Biotech

Cornerstone Search Group Published: March 30, 2017
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RETAINED SEARCH: U.S. Quality Assurance Leader (Top U.S. QA. role); Start-up US Group for EU Innovative Biotech

Location:  NJ

Unique & Attractive Features about this Opportunity:

  • Leadership: Serve as local U.S. Quality Assurance leader internally, and as QA point of contact/ Subject-Matter-Expert to HQ and to FDA.
  • Relationships: Create, build and maintain relationships with key strategic internal stakeholders and external stakeholders (FDA).
  • New Treatment: Work with novel therapies with diverse modalities for preventive care of food & pediatric allergy patients.
  • Save Lives for an Unmet Need: Contribute significantly to finding safe, effective, and patient-friendly therapy for food and pediatric allergy patients.
  • Build: Help build and train U.S. QA department, including implementing Quality systems for the local U.S. activities.

Key Deliverables:

  • This is a broad Lead U.S. QA role responsible for ensuring the quality assurance of activities conducted in the U.S. are in compliance with US regulations, in particular issued by the FDA.
  • Build and set up U.S. QA department; lead and train employees of QA regulations; serve as a point person for the documentation and training site.
  • Establish and document all SOPs & implement QA responsibilities for U.S.
  • S. point of contact for communication with FDA, ensuring all quality regulations and ethics metrics have been met pre-launch and post-launch (in U.S. and Canada).
  • Work closely with HQ team to ensure the Company is U.S. compliant with FDA.
  • Significantly contribute to the strategy, development, logistics and processes that will efficiently and effectively support U.S. QA efforts; this person will implement the Quality systems for the local U.S. activities.
  • Ensure compliance and application of the processes is defined for Pharmacovigilance and Medical Affairs groups.
  • Ensure commercial and communication (public and professional advertisements, scientific communications, training, events…) activities are aligned with US regulations and QA by participating in the definition and documentation of processes.
  • Assure U.S./CAN support for audits Quality of local providers and/or partners.
  • Assure U.S./CAN batch tracking and recall, as well as claims.


  • 8+ years of Quality Assurance experience within the pharmaceutical, or drug/device industry.
  • Advanced Degree in Pharmacy or Science is preferred.
  • Strong core competencies in QA operations activities, implementing Quality systems, building and leading a QA group, document management, claims, deviation management, corrective and preventive actions (CAPA), etc., in compliance with established SOPs and U.S regulations.
  • Experience in interacting with FDA in context of submitting proper Quality documentation and serving as the QA Lead for inspections and audits; up-to-date knowledge of US Quality regulations and guidelines.
  • Prior experience supporting company and products within Commercial activities.


Viola Serrano | Director, Executive Search


Life Sciences Executive Search

6 Campus Drive | Parsippany, NJ 07054

p 973.656.0220

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