Employees Create the Evidence that Matters

As demand for the rapid delivery of new pharmaceuticals, biotechnology and medical devices to identify, treat and prevent disease is on the rise, never has the need for conclusive evidence of product efficacy and effectiveness been greater. United BioSource Corporation is focused on meeting this growing demand for evidence.

UBC: a fast growing, full range, global pharmaceutical services organization.

Delivering evidence-based services and solutions depends on the quality and dedication of our staff. We seek the brightest, most talented professionals in the industry.

Whether you are launching a career or seeking new challenges, UBC fosters personal and professional growth on diverse and challenging projects amid highly respected scientific, clinical and data professionals, and offers a robust compensation and benefits package.

Come join our team to deliver the scientific evidence helping products succeed in the real world and saving millions of lives because Evidence Matters.

Position Title: Quality Assurance Manager

Position Overview:
The Quality Assurance Manager is responsible for the definition, implementation and adherence to a Quality System for all UBC Training and Education Group deliverables. The Quality Assurance Manager is also responsible for managing all audits. The QA Manager has a dotted line reporting to the Corporate Director of Regulatory Compliance.

Essential Duties and Responsibilities: Other duties may be assigned.

	Define, implement and maintain an overall Quality System for UBC Training and Education Group o Identify, document and train staff on required processes and procedures o Analyze customer and regulatory requirements and assess their effect on the quality system
	Reeview and recommend enhancements to UBC Training and Education Group SOPs and department guidelines based on results of sponsor/internal audits
	Manage the development, updating and implementation of enterprise SOPs as well as department guidelines in conjunction with department management
	Perform internal audits to ensure compliance with all SOPs and department guidelines
	Develop and maintain project QA plans and an audit schedule
	Facilitate and manage on-site Sponsor and Regulatory audits o Develop and implement standard audit preparation and execution processes o Maintain audit master schedule o Maintain QA metrics regarding types of audit and reviews conducted o Conduct vendor assessments and ongoing audits as necessary o Track audit findings and address non-conformities. Manage implementation of planned responses
	Participate in IT development project teams as QA representative o Ensure compliance to SDLC o Review and approve project documentation for QA and compliance
	Ensure compliance with all applicable regulations and clinical practices o FDA Regulations o ICH GCP Guidelines o SOPs and Department Guidelines o International Quality System rules

Requirements: (Knowledge, Skills, Experience):

	Bachelor’s Degree in applicable field
	A minimum of five (5) years in Quality Assurance or equivalent
	Knowledge of ICH GCP Guidelines and FDA Regulations
	Knowledge of International Quality System Regulations
	Pharmaceutical industry experience required and clinical study experience preferred; CNS experience, training and/or education background valued
	Excellent written and verbal communication skills
	Strong project management and organizational skills
	Ability to manage own time, proactively identify what needs to get done and prioritize multiple tasks.
	Ability to work with all levels of staff and disciplines.
	Good computer skills in particular, Microsoft Office Suite.
	Knowledge of IT processes and SDLC

How to Apply:

If you are interested in joining the UBC team, please forward a cover letter describing your career interests and qualifications, along with a copy of your CV or resume to:

United BioSource Corporation
Attention: Careers
575 E. Swedesford Road
Suite 101
Wayne, PA 19087 USA

Email: training.careers@unitedbiosource.com