Manager, GCP Quality Assurance

Target PR Range:

90-100/hr

• Depending on experience

SUMMARY/JOB PURPOSE

(Basic purpose of the job):

• The Manager, GCP Quality Assurance applies established knowledge and experience with Good Clinical Practice (GCP) regulations, guidelines and local legislation to lead and execute GCP QA activities in support of global clinical trials by providing guidance and support on the interpretation and application of Good Clinical Practice (GCP) regulations and guidelines to Clinical teams.

This role will contribute to ensuring the conduct of clinical trials, documents, investigator sites, systems and vendors is compliant with the requirements of GCP through the conduct of audits of clinical studies, investigator sites, internal processes, vendors (e.g., CROs), and documents (e.g., CSRs). The Manager should have a solid knowledge of

ICH GCP E6

(R3) and applicable 21 CFR regulations and be able to apply that knowledge to support clinical trial activities. The Manager will also partner with study teams to create a quality culture within, provide compliance guidance and contribute to reaching a sustained state of inspection readiness.

ESSENTIAL DUTIES/RESPONSIBILITIES

• Partner cross-functionally to support the successful and compliance execution of clinical trials
• Contribute to the development of the GCP audit plan
• Conduct and/or oversee the conduct of audits of clinical investigator sites, internal GCP systems and processes, external vendors and clinical trial documents
• Identify and report systemic issues and improvement opportunities with the assistance of management/senior auditor, as necessary
• Independently perform audits, including preparation, conduct, presentation and reporting
• Assist in assessing proposed CAPA plans
• Support GCP Regulatory Authority inspections
• Contribute to the continued development of a quality culture at

SUPERVISORY RESPONSIBILITIES

N/A EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS

Education:

• BS/BA preferably in life sciences or STEM disciplines and 10-20 years of related experience; or,
• Equivalent combination of education and experience

Experience:

• Required minimum of 5 years of related experience in biotech, pharmaceutical or related industry
• Working knowledge of

FDA, EMA, ICH GCP

guidelines and GCP regulations (e.g., ICH E6 (R3)

• Experience working with CROs and vendors
• Experience planning, conducting and reporting all types of GCP audits (e.

g., investigator sties, processes, vendors)

Knowledge, Skills and Abilities:

• Identify GCP non-compliance and communicate significant audit findings to auditees in a professional and factual manner
• Effectively manage multiple projects in a fast-paced environment
• Collaborate and negotiate effectively in a dynamic, cross-functional environment
• Work independently and within a team environment
• Strong written and verbal communication and presentation skills Travel approximately 30%