Senior Manager Rdq Clinical Auditing

hace 6 días

Madrid, España Bristol Myers Squibb A tiempo completo

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Position Summary**

Conduct Good Clinical Practice (GCP) audits of clinical investigator sites, vendors, internal systems/processes, and pre-qualification audits. Act as an expert in specific GCP related areas, co-investigate alleged cases of scientific misconduct and may coordinate local and major Health Authority Inspections. Represent RDQ-CTQA on due diligence activities for vendors.

**Position responsibilities**
- Perform GCP audits of clinical investigator sites, vendors and/or internal systems including pre-qualification audits to assess regulatory compliance (may function as a lead auditor for wide range of audit types)
- Act as an expert resource for a certain GCP topic within RDQ-CTQA and may function as SME (providing advice and counsel) for the concerned area for the development of SOPs (QA and stakeholder-based) and delivery of training to auditors in the area of expertise
- Lead and/or participate into GPS and/or BMS company processes and improvement initiatives
- Support other areas within RDQ in the creation and maintenance of project/study audit plans; prior to and post audits by sharing newly identified risks to be explored in future audits.
- May assist/coordinate local and major markets HA inspections
- Represent RDQ-CTQA position during internal meetings
- Perform peer audit report review as required
- Represent department on due diligence activities for vendors
- Co-Investigate alleged cases of scientific misconduct or corporate compliance R&D related investigations as assigned

**Experience requirements**
- Profound demonstrated working knowledge of principles and concepts of QA including those related to QRM and Critical Thinking
- Profound GCP wide range of auditing skills including audits at vendors, systems supporting clinical trials as well as profound inspection coordination skills
- Profound knowledge of ICH-GCP guidelines and working knowledge of GxP Guidelines/regulations.
- Profound understanding of the drug development process and regulatory environment
- Profound knowledge of other disciplines in stakeholder’s organizations to influence and support improvements in products, processes and services
- Minimum of 4 years in clinical QA auditing and / or 6 years of work experience in clinical research and/or GCP related QA environment

**Key competency requirements**
- Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for GCP audit findings or issues consistent with company policy, regulatory references and business strategy.
- Excellent oral and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
- Excellent negotiation and influencing skills collaborate effectively with cross-functional team members
- Fluent in English and other languages as applicable to assigned region of responsibility
- Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment

**Travel required (nature and frequency)**
- Approximately 25% travel to perform audits and attend professional meetings and seminars.
- Approximately 5 overnight absences per month

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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