Clinical Auditor, GCP at Waltham

Job Description

Clinical Auditor, GCP

Responsible for conducting the GxP (GLP/GCP/GMP) external and internal audit programs. This position is directly responsible for ongoing maintenance and continuous improvement of these quality programs. The Corporate QS Compliance Auditor will assist with inspection activities (preparation, conduct, and responses) for clinical regulatory inspections internally and externally, at investigator sites, when appropriate. Also assists the corporate office by providing inspection readiness support during GMP inspections. Develops and provides GCP and related training in support of compliance systems and quality improvements. Provides leadership in cross-functional teams to identify and address compliance risk areas related to clinical trial research. Partners with various internal and external groups to quickly analyze problems, identify and communicate options, and recommend and assists with development of appropriate solutions. Provides guidance in the development of corrective and preventative action (CAPA) plans following identification of compliance issues/concerns; monitors progress to ensure successful completion/implementation of CAPAs.

This role is also responsible for technical development of personnel,leading others through audits and ensuring the quality of deliverables within their purview.

DUTIES / ACTIVITIES:

• Responsible for driving culture through values and customer service standards


• Accountable for outstanding customer service to all external and internal customers


• Develops and maintains effective relationships through effective and timely communication


• Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner

PRINCIPAL RESPONSIBILITIES AND DUTIES

• Perform GXP audits based on a defined audit plan within specific time constraints.


• Schedule and conduct Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) Audits of processes related to clinical and business operations, clinical safety and pharmacovigilance, clinical research and pre- andpost-marketed trials.


• Conduct audits of Clinical Investigator sites, Institutional Review Boards (IRB),Suppliers /Vendors, databases, clinical laboratories,Trial Master Files (TMF), clinical data, systems and processes.


• Conduct GMP audits of manufacturing sites.


• Ensure compliance with companys procedures and regulatory requirements.


• Deliver audit findings and risk management evaluations to CQSComplianceManagement, Clinical teams and senior management.


• Obtain and secure Clinical teams commitment on action plan and follow-up on agreed upon actions.


• Identify opportunities for GCP and business process and internal/external controls to assure high quality standards for GCP systems/processes and clinical safety and pharmacovigilance compliance with company policies and prevailing government regulations.


• Assess clinical and business systems and processes to provide CQS Compliance Management with anevaluation of internal and external controls.


• Provide regulatory expertise and process optimization to customer divisions, clinical teams and conduct field interaction to complement and reinforce Quality programs.


• Develop audit reports, coordinate action plans and follow up with auditee to assure prompt and adequate completion of agreed upon actions.


• Contribute in the development of Clinical Research, Safety and Clinical Quality and Compliance systems and standards.


• Assist in establishing and conducting inspectional readiness training for internal departments and Investigational Sites.


• Serve as clinical quality subject matter expert (SME) for regulatory inspections, as needed.


• Create, revise and review standard operating procedures used for clinical trials and auditing.


• Perform any other tasks as requested by Management to support quality oversight activities


• May participate in activities to set strategic direction of Corporate Clinical QA including:


• Conduct presentations on quality issues and initiatives at cross-functional meetings.


• Development, implementation, and oversight of quality activities. These activities include, but are not limited to the following: The GCP/GLP Audit Program, GCP Training, Audit/Inspection Support, CAPA review and approval.


• Development and reporting of quality and compliance metrics related to CQS Compliance audit activities


• Determine escalation procedures for issues arising from CQS Compliance activities and drives process improvement activities.


• Coach/mentor staff as a means to ensure performance and professional development


• Establish/maintain effective cross-functional team communications to advance quality activities of company.


• Other duties as assigned.

EDUCATION
MinimumBA/BS Degree in biological sciences, chemistry, or related field required.
Certification in ASQ-CQA, ASQ-CBA, SQA - RQAP-GCP, SoCRA CCRP or similar program required. (If you do NOT have this, one of these will be required to complete after you start)

EXPERIENCE AND REQUIRED SKILLS

• 3-5 Years GxPauditing work experience in the medical device, pharmaceutical, or biotech industry


• Extensive knowledge of good manufacturing, clinical and laboratory practice (both US and international) Strong understanding of FDA/ICH regulations and Quality Systems; Solid background in Quality Assurance/Systems. Experience in a clinical quality assurance department or clinical quality systems group serving in a quality role desired


• Outstanding auditing skills and attention to detail with audit program implementation including interpreting regulations, guidelines, and identification of compliance issues.


• Demonstrate broad expertise related to the principles and application of GxP quality and regulatory compliance.


• Demonstrate strong aptitude for facilitating group or project team endeavors, and building team unity.


• Demonstrate ability to effectively communicate and influence the outcomes of the decision making process


• Display highly developed organizational leadership qualities and effective coaching abilities


• Listening, interpreting and summarizing information


• Excellent communication and writing skills; Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals


• Ability to work both independently with direction and within project teams to attain goals


• Expertise in reviewing, revising and writing Standard Operating Procedures (SOPs)


• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)


• Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines

Randstad Technologies is an EOE-M/F/V/D and is a wholly owned subsidiary of Randstad Holding nv, a $20.0 billion global provider of HR services and the second largest staffing organization in the world.

Job Requirements

 
Country: USA, State: Massachusetts, City: Waltham, Company: Randstad Technologies.