Senior Manager - GCP Quality Assurance - Clinical Research Industry

Core Purpose of the Role:

The QA Group Leader is responsible for managing the GCP QA auditors team and to performing the study based audits, vendor audits, assess the systems and practices for improving the GCP Quality System practices independently and shall consult with GCP Quality Head as required by The company, Corporate Quality Policies.

This QA Group Lead must be comfortable exercising latitude in ensuring the The company Clinical Development Operating Unit (OU) and its facility is compliant with the national and international GCP Quality System, the quality (GxP) regulations and standards it is built on and ultimately is audit / inspection ready to have good outcome.

Comfortable working and communicating professionally with others to reach understanding and agreement as necessary.

Role Accountabilities:

- Schedule, personally conduct and/or manage resources, for GCP QA audits which will enable the BE/BA/Phase I operational activities at clinical development operating unit (OU) to ensure quality and compliance to national and international regulatory requirements.

- Develop risk-based audit plan focusing on ethical conduct, medical care of subjects, adherence to protocols, GCP requirements for BE /BA/Phase I operations and facility audits.

- Provide personal oversight for and /or participate in audits of BE /BA/ phase I activities and review clinical, bioanalytical , pharmacokinetic/statistical data and documents that will be submitted to sponsors / regulatory authorities.

- Provide oversight of GCP QA auditors to develop specific audit plans, review and assess internal audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), regulations, and best practices.

- Collaborate with the appropriate operations team in follow-up to external audits to ensure resolution of audit findings in accordance with industry best practices.

- Collaborate with clinical development operations in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.

- Consult with operations regarding perceived GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.

- When indicated/required perform onsite / remote vendor audits and provides follow-up as indicated.

- Provide follow-up corrective action with proposed and contracted vendor services.

- Lead/assist with investigations of misconduct, serious GCP breach and other noncompliance issues.

- Identify and appropriately escalate critical quality issues to GCP QA HOD.

- Perform / Oversee and root cause analysis (RCA) and corrective action preventative action (CAPA) process.

- Perform /Oversee internal process audits, due diligence, system audits, GCP document audits including trial master file (TMF), and 21CFR part 11 audits.

- Periodically maintain and report GCP QA team activity metrics, study quality metrics and trends for assigned program(s) to GCP QA HOD

- Assist GCP QA HOD/management in the readiness and hosting of regulatory agency inspections.

Specific requirements for this role

1. Experience: 18 to 25 Years of relevant technical, managerial and leadership experience in Clinical Research Industry.

2. Education: M.Sc./M. Pharm/M. Tech in Basic Medical Sciences/ Life Sciences/Biotechnology.

Skills and Capabilities

- Performing and managing Quality Assurance audits in GCP environment and with at least 10 years in team managing/leading capacity.

- Sound fundamental technical knowledge in BE /BA studies/Clinical research/Drug development/Basic medical sciences and pharmacology.

- Thorough knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.

- Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment