RETAINED SEARCH: U.S. Quality Assurance Leader (Top U.S. QA. role); Start-up US Group for EU Innovative Biotech
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.
- 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
CORNERSTONE SEARCH GROUP, LLC – www.cornerstonesg.com
Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054