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Director / Senior Director Quality Assurance - CRO

Blue Bix
Exton, PA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Description

This QA leadership role is responsible for closely partnering withour Global Head of QA, BU leaders and their QA leadership teams, and support Bioanalytical,Biologics, Central Lab Services, CMC and Safety/Toxicology Services. Based onthe expertise, the role may have international scope.

Key Responsibilities

o Partnering with Global Head of QA, monitorcompliance with local, state, federal and international regulations throughinternal audits, review, and approval of Standard Operating Procedures (SOPs)and other Quality Systems reports.

o Maintain the effectiveness of QMS, processes,and procedures including Document Control, Deviations, Change Control, CAPA& Quality Management Review.

o Develop and manage SOPs and Work Instructions tosupport GxP quality systems, risk management, data protection and inspectionsreadiness.

o Proactively train and prepare staff to supportsponsor visits, regulatory authority inspections, hosting regulatory compliancevisits and communications withregulatory agencies.

o Facilitate accurate and timely responses toexternal inspections and regulatory bodies.

o Serve as a project lead or partner with BUleaders and QA teams on quality and/or process improvement projects.

o Develop, maintain, and monitor internal trainingand compliance including Quality Systems, Regulatory policies and proceduresincluding document control and records management policies and procedures.

o Coordinate and support Supplier and VendorQualification processes and maintain applicable documentation and records.


o 10-15 years of Quality Assurance experiencegained in CRO, pharma or biotech industries including 8+ years in a leadershiprole.

o BS or MS degree in life sciences required.Advanced degree is preferred.

o Expert knowledge of GXPs (GLP, GCP, GCP)regulations/guidelines and their application.

o Experience in leading and supporting regulatoryinspections including FDA.

o Excellent negotiation, presentation,communication, and people skills.

Proficient with MS Officeproducts including Word, Excel, Outlook, and PowerPoint.

Blue Bix


Exton, PA
19341 USA