Senior Director Quality Assurance (GCP) - New Jersey - Pharma

Senior Director Quality Assurance (GCP) - New Jersey - Pharma

Senior Director of Quality Assurance required to work for an exciting boutique Pharmaceuticals organization. They are an end-to-end pharma that are making serious innovative progression in Therapy Areas that unfortunately currently only have minimal treatments.

This position will be based on their New Jersey site located close to Fair Lawn.

JOB TITLE

Senior Director of Quality Assurance / Senior Director of QA

LOCATION

USA / New Jersey / Fair Lawn / Paramus / Bergen County

SALARY

Highly competitive salary (DOE)

ROLE/DESCRIPTION

• You will be the "go to" person for responsible for the oversight and management of the organizations Quality Assurance activities
• In a nutshell - you will take GXP oversight of CRO compliance, developing audit plans, regulatory guidance and support to study teams, inspection readiness
• As the Senior Director of QA you will spearhead the quality oversight of GLP, GCP, and GMP activities; SOP development and maintenance, internal and external audit conduct, development and commercial stage batch release program
• Your main areas of responsibility will be: development and implementation of strategy compliance, ensuring an audit plan is implemented for all products at all stages, developing inspection readiness program (and acting as a representative), organizational direction and acting a technical resolve for all things Quality
• Other expectations include presentation of periodic reports outlining trends, training and development of departmental staff

REQUIREMENTS

• A proven track record and 15 years (minimum) of Clinical Quality Assurance Experience
• Bachelor''s degree in a science discipline
• In depth Knowledge of GCP requirements, regulations and Quality (US/EU etc.); ICHE6, 21 CFR Part 50, 54, 56, 312, 314, and 21 CFR Part 11
• Significant exposure to Phases 1-4 clinical trial within the drug development life cycle
• Meticulous with written skills and experience of prioritising / planning
• Unparalleled communication skills and the ability to influence others
• Be a real life "self-starter"

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Senior Recruitment Consultant David Fearnley on +1 (718) 514-9604 or email dfearnley@i-pharmconsulting.com. If this role is not suitable, David is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

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