Job Description

Position Summary  

• Support the GCP audit strategy and plan for the clinical program by ensuring that corrective measures to audit findings are assessed in a timely manner, followed up with internal and external contract organizations and efficacy evidence obtained for significant issues

• Communicate with internal and external points of contact to report on the timeliness of corrective action response

• Develop metrics and reporting mechanisms both internally and externally on the audit response process

• Partner with Clinical Study teams to ensure studies are compliant with applicable regulatory requirements through operational activities and training

• Execute Clinical QA, GxP Compliance Audit and Inspection Readiness goals and objectives 

Responsibilities  

Execute GCP oversight, compliance audit response system and partner with Clinical Study Teams, Clinical Investigative Sites and external vendors to ensure compliance during clinical trials with ICH guidelines, FDA/EMA/applicable global health authority regulations related to GCP & GVP

• Participate and potentially lead GCP audits which includes but is not limited to investigational site, Service Providers, CROs

• Represent QA on clinical study team’s operational activities

• Promote performance improvement with the Clinical Study Team and key stakeholders through a proactive and engaging compliance audit and inspection readiness system 

• Provide input into department specific standards and SOPS in support of the Quality System and proactive quality program

• Actively support inspection readiness activities and associated Health Authority Inspections

• Collaborate with internal and/or external stakeholders to ensure management of GCP compliance issues and risks

• Perform any other tasks as requested by the Executive Director of Clinical QA and/or Executive Management to support Quality oversight activities

Requirements 

• Bachelor's Degree is required in Biological Science, Chemistry or related technical discipline.

• 3+ years’ experience in Biotech/Pharmaceutical industry

• Working knowledge of FDA/EU and ICH – GxP regulations and guidelines

• Experience working with Contract clinical, Service Providers, and other entities which provides GxP contracted services

• Capable of collaboratively engaging with external 3rd parties to effectively execute the audit and inspection readiness strategy and approach.

• Flexible in the face of shifting needs and/or priorities.

• Able to interface well with all levels of personnel, including peers such as: Clinical, Safety, Clinical Affairs, Data Management, Biostatistics, Regulatory, Technical Operations, Quality Operations, Supply Chain and Project / Program Management.

• Experience with computerized systems and compliance requirements, involving both on-premises and hosted environments.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.