Sr. Director, Quality Assurance w/CRO industry exp.

Manages the activities of sponsor audits/agency inspections, and ensures appropriate follow-up activity is conducted, interacts with Senior Management to maintain a compliant working environment by providing constructive feedback from audits, manages the development of Standard Operating Procedures and Specifications for the Quality Assurance function; ensures that Procedures from other operational departments are reviewed and updated in a timely fashion.  Provides and oversees ongoing GCP education and training to various individuals/groups, prepares company personnel for sponsor audits/agency inspections.  Ensures that company operates in compliance with applicable regulations and guidelines relating to Good Clinical Practices (GCPs) through the management of routine study audits conducted by QA.

Minimum Requirements:

·         Bachelors degree in a health science or other related area

·         10+ years of clinical research experience in CRO pharmaceutical industry

·         Must have a thorough familiarity with ICH GCP and applicable regulations/guidelines that pertain to clinical research

·         Must be skilled in Quality Assurance practices and procedures, as well as the clinical research process

·         Must have proven/documented experience in global audits and working knowledge of international regulations

·         Must have strong interpersonal skills and be able to build constructive relationships both internally and with sponsor personnel.

·         Must have good management and leadership skills.

·         Excellent communication skills are required, both written and oral

·         Strong PC skills, including experience using MS Office, MS Outlook, and MS and Netscape Web Browsers, or equivalent

Come be part of our team where your talents will be appreciated and rewarded and perform work that will impact many lives.

Email resume with salary requirements to hr.usa@pierrelgroup.com or fax to 610-975-0548.

Pierrel Research USA, Inc. is not seeking assistance nor accepting unsolicited resumes from search firms for this employment opportunity.