Clinical Quality - Boudry, Schweiz - Bristol Myers Squibb

Bristol Myers Squibb

Geprüftes Unternehmen

Boudry, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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

The Director, Therapeutic Area (TA) Quality Lead will be mainly responsible for managing the Therapeutic Area activities from a quality perspective and delivering the full range of quality related activities in support of the TA.

The incumbent is a single point of contact for R&D Quality for the Therapeutic Area.

Key Responsibilities

Design and implement endtoend quality strategy for respective Therapeutic Area Ensure successful Health Authority (HA) engagement.
Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA;
Engage in appropriate activities to support product submissions.
Establish strong partnership with business stakeholders.
Interaction with leadership in R&ED and GDD, Patient Safety and Regulatory to influence decisions impacting quality and compliance related to the TA
Interactions with peers in R&D Quality and Global Quality
Interactions with external auditors from partner companies and health authority inspectors during the conduct of health authority inspections
Contact with appropriate technical, supervisory and management personnel internally and externally (BMS sites, vendors, partners etc.) in the conduct and reporting of potential serious breaches, inspections, and audits
External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers
Internal engagement as needed with relevant R&D partners and corporate functions

Other

Lead multidisciplinary or crossfunctional work/project teams; serve as part of strategic team(s) within the group/discipline
Lead and/or contribute to the implementation of largescale initiatives and/or organizational changes (such as functional optimization) that affect the department
Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines
Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
Provide input in the global audit plans based on identified signals/trends/risks/gaps
May influence the external environment through interactions with regulators, trade associations, or professional societies
Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems

Research and Development Quality is responsible for the following:

Defines and oversees the global quality strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems are implemented and in use
Translate QMS elements into the R&D processes and ensure feedback to the central QMS team
Lead the Quality and Compliance R&D Escalation Process
Ensure GLP systems are in place, studies are audited and lead analytical path of Translational Medicine
Oversee the Data generation and data integrity from laboratory work and nonclinical phase projects
Ensure Quality is Designed into nonclinical trials and clinical protocols using data and information from discovery phase, nonclinical and clinical studies
Oversee process development, manufacturing and release of clinical supplies to clinical trials protocols
Advice on Franchises (including Cell Therapy) and Clinical Operations development projects
Lead Qualification of vendors and manage external Quality Systems
Execute GCP and Pharmacovigilance audits and support GCP and Pharmacovigilance Regulatory inspections
Ensure that GxP followup CAPA activities are completed
Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs
Contribute to develop Quality Management Systems training elements

Qualifications & Experience

Education and Experience:

B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance

**Req