Associate Director Therapeutic Area Quality
vor 2 Wochen
**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.
**Functional Area Description**
Brief purpose of the functional area, including basic description of responsibilities and deliverables.
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 non-clinical phase projects
- Ensure Quality is Designed into non-clinical trials and clinical protocols using data and information from discovery phase, non-clinical 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 follow-up 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
**Position Summary**
- Should be pulled from the appropriate Job Description data in Workday, appropriate source per department, or a contractor agreement.
- Several top-line sentences in plain text, focused on key accountabilities or duties.
- Ideally no more than 75 words.
- Avoid internal jargon or acronyms.
- The Associate Director, Therapeutic Area Quality will be mainly responsible for delivering the full range of quality related activities in support of the molecule._
- Key responsibilities of the Associate Director, Therapeutic Area Quality include: 1) Design and implement end-to-end quality strategy for assigned Molecule; 2) Ensure successful Health Authority (HA) engagement; 3) Manage for cause, critical and/or complex quality issues as well as serious breaches for the assigned molecule; 4) Engage in appropriate activities to support product submissions; 5) Establish strong partnership with business stakeholder._
**Position Responsibilities**
- Should be pulled from the appropriate Job Description data in Workday, appropriate source per department or a contractor agreement.
- Typically 5-9 bullet points; each describing a distinct and primary responsibility of the role.
- Avoid generic comments such as “works well with others”, etc.
- Design and implement the quality strategy for the Molecule
- assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the Quality Assurance Program where necessary
- Identify and drive continuous quality process improvements as a consequences of audits, assessments, inspections, trends/metrics and root cause analysis
- Lead implementation of Quality by Design principles
- Develop, implements and maintain the program quality plan summarizing the quality strategy by summarizing the result of evidence of quality activities
- Integrate end -to end quality principles and review project milestones with R&ED/GDD
- Establish strong partnership with business stakeholder
- Seek to understand and evaluate their priorities
- Actively participate in and make meaningful contributions
- Deliver independent expert support and propose solutions
- Present key data (compliance, conformance, issues and risks) to drive decision making
- Manage for cause, critical and/or complex quality issues as well as serious breaches for the assigned molecule
- Engage in appropriate activities to support product submissions
- Ensure successful Health Authority engagement
- Demonstrate implementation of quality strategy to Health Authorities
- Create the quality plan to be shared with Health Authorities
- Prepare for inspections and support inspections
- Participate/provide expertise in in licensing activities as applicable
- Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
**_Other_**
- Contribute to multi
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