Manager GQ-CT&S Audits and Inspections - Bristol Myers Squibb - Braine-l'Alleud

The Manager will work in the GQ CT&S Audits and Inspections group. This group audits all processes related to clinical research and pharmacovigilance.

This role reports to the regional management within GQ CT&S Audits and Inspections.

The key objectives of this position are;

• To conduct Good Clinical Practice (GCP)
• To coordinate regulatory inspections.
• To act as an expert in specific GCP-related areas

The candidate will be responsible for:

• Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance;
• Apply audit principles, procedures, and methods; Prioritize and focus on matters of significance;
• Collect information through effective interviewing, listening, observing and reviewing documents, records and data;
• Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
• Assess those factors that may affect the reliability of the audit findings and conclusions; Perform and document analyses of audit findings where indicated:
• Prepare clearly-written, concise, accurate and evidence-based audit report; Maintain audit database;
• Review and assess received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
• Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines.
• Provide advice and counsel concerning GCP regulatory requirements.
• Act as project-specific liaison (Project Coordinator) and provide input into audit plans. Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.
• May provide mentoring for new GQRC-CT&S staff, as needed.

Requirements

• University graduate, Life Sciences degree preferred
• Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at Ieast 4 years in the pharmaceutical industry or equivalent.
• Minimum 2 years technical auditing or equivalent; PV and GCP auditing preferred.
• Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication;
• Good understanding of the drug development process;
• Excellent oral and written communication; Fluent in English,any other languages are a plus
• Sense of diplomacy and discretion; Maintains the confidentiality and security of information, data, documents and records;
• Demonstrates commitment to delivering high-quality work product;
• Knowledge of relevant BMS policies and consequences of using sampling techniques for auditing;
• Strong critical thinking to analyse complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
• Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
• Develops strong working relationships with key stakeholders;
• Ability to manage competing priorities.