Quality Assurance Site Head

Description:       

Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases.

Placing the patient at the heart of our priorities, demonstrating ethics and respect towards each person, Erytech is focused on becoming a global leader in rare cancer and orphan diseases space.

Since our inception, our mission has been to make a sustained investment in R&D in order to meet the challenges of public health and to offer innovative therapies to target markets with high unmet medical needs, particularly in the field of cancer.

Our company has been classified as a Pharmaceutical Facility and develops its activities in close collaboration with health professionals, particularly physicians and pharmacists.

Duties: 

The successful candidate will manage QA Team at a Sterile Drug Product Manufacturing site. Manage implementation and ensure application of required quality activities in compliance with cGMPs and applicable Regulatory Files. Lead Inspection Readiness Program to ensure successful Inspections out-come and act as site QA contact during FDA Inspections. Contribute to Erytech continuous quality improvement efforts.

Release Drug Products for clinical trials and/or commercial use and manage all related QA activities in compliance with cGMPs, such as, but not limited to investigations, Change Controls and Annual Product Reviews.

Lead implementation of QMS at the site in collaboration with Corporate Quality.

Manage site cGMP training program and provide training as needed.

Identify, create and implement quality system and process improvements

Provide quality support and guidance to other departments.

Manage site QA team

Propose and implement meaningful quality performance indicators

Contribute to supplier qualification program

Contribute to Corporate QA efforts as required.

Qualifications:  

Bachelor’s or Master’s degree and with a minimum 8 years’ experience in a pharmaceutical/biotech environment of which minimum 5 years in QA.

Experience with FDA Inspections

Sterile Manufacturing is a must have!

Experience in management

Experience in supplier audits is an asset

Strong interpersonal and communication skills are required

Willingness to travel up to 10% of the time  

Ability to train in Philadelphia.