Job Details

Candidates with autism, neurodivergence and/or disabilities highly encouraged to apply.

SourceAbled is looking for Compliance Manager - GCP Auditor candidates for a direct hire position with our pharmaceutical client. You will be responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP portfolio/programs/entities. This role is responsible for GxP Oversight and for assuring the compliance of projects, products and programs with our client's Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

It is your knowledge and skills that will help in making our client ready to achieve new milestones and help patients across the globe.

Position Responsibilites

• Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable global regulations

• Independently conducts more complex routine/non-routine investigator site audits, support process audits, and manage/lead with minimum oversight

• May engage with more complex audits or serve as a reviewer of low complexity, outsourced audits

• Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments

• Has GxP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GxP regulations and guidelines, as well as local regulations

• Works with RQA colleagues on cross GxP audit plans as required

• Provides clients with recommendations and influences to meet the changing business need with support from Manager

BASIC QUALIFICATIONS

• BS degree preferably in pharmaceutical or natural sciences, or equivalent

• 5+ years of operational or GCP (good clinical practices) auditing experience required

• Demonstrates knowledge of ICH GCP and global regulations

• Demonstrates solid working knowledge of business concepts and quality operations

• Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge

• Understands quality and auditing frameworks and application

• Exhibits proficient organizational and project management skills

• Demonstrates technical writing skills

• Ability to identify trends within data and apply insights to make recommendations

• Understands Regulatory environment with the ability to interpret and apply regulations

• Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes

• Ability to synthesize information and draw conclusions

• Experience evaluating and understanding quality standards or their application

• Suggests new audit techniques and new controls

• Acts as SME in specific specialty (e.g. gene therapy, non-interventional studies, etc.)

PREFERRED QUALIFICATIONS

• Preferred qualifications

  •Knowledge of core regulations governing the auditing space (FDA, Global Regulations, etc.)Exhibits working knowledge of data analytics and interpretation capabilitiesA Manager must have at least one specialized knowledge area or two minor specializations  

   

  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • The travel requirement may be approx. 40%