Director, Clinical Supply Chain Quality - Qualified Person
Director, Clinical Supply Chain Quality - Qualified Person
Apply locations Dublin - IE time type Full time posted on Posted Today job requisition id R1591093
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. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
The Role
The Director, Clinical Supply Chain Quality- Qualified Person is a critical management position within the PD/R&D Quality organization that is responsible for the oversight of clinical supply chain quality activities & Dublin Site Quality Operations. The Director, Clinical Supply Chain Quality is responsible for Supply Chain related activities including but not limited to processes such as QP release/certification, Use Date Extensions, ISR studies, IMP supply and management at sites & 3rd party logistics risk management. The position is also Quality Lead for the PDQ Dublin team, leading a team of QA professionals with responsibility for Site Operations, QP release, GMP licenses. The position provides leadership for the identification and resolution of critical quality issues that may affect BMS. The Director, Clinical Supply Chain Quality will act as Quality Culture ambassador across CSC, with responsibility for influencing senior leadership across BMS with respect to the importance of building continuous quality improvements into the organization. Reports to Senior Director, Clinical Supply Chain Quality. Supervises QPs, QA Operations personnel (Associate Director, Senior Manager).
Key Duties and Responsibilities:
* Accountable for Health Authority inspections and audits across the supply chain
* Leads Quality Council and proactive risk identification utilizing metrics and digital methods
* Oversees/provides CSC compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
* Promotes high standards of quality, compliance, and process excellence through oversight of procedure development/enhancement as well as by leading or contributing to supportive initiatives to ensure delivery of business goals.
* Develop and implement quality strategy to oversee vendor quality (3PLs)
* Oversees the development and implementation of the digitalization strategy for Clinical Supply Chain Quality including automation, virtual reality.
* Incorporate global regulatory trends and changes into Supply Chain Quality
* Engage with executive management and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement; drive issue resolution
* Continually evaluate the strategic approach, drive changes in PDQ processes, and modify the PDQ program to meet the changing needs of the organization, regulatory environment and industry best practice
* Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products, to business partners and senior management
Qualifications, Knowledge and Skills Required:
* Eligible to be a Qualified Person
* BS/MS in relevant Science or Engineering discipline and 15+ years of experience in managing Quality functions
* Expertise in GMP compliance and global, local and EU/US regulations
* Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers is required
* Experience with implementing and overseeing GMP operations in a clinical manufacturing facility is required
* Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
* Background in IMP is required
* Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams is required
* Experience in continuous improvement, operational excellence and six-sigma is desired
* Demonstrated excellence in written and verbal communication
* Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
* Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
Why you should apply
* You will help patients in their fight against serious diseases
* You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
* You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave, access to BMS Cruiserath on-site gym and life assurance
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