Sr. Director, Quality Systems & Compliance

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. Read more:

Position Summary

The Sr Director, Quality Systems and Compliance, is a full-time position located at the BMS Bothell Manufacturing Plant (JuMP) located in Bothell, Washington. The primary focus for this role is to lead the Quality Systems and Compliance teams to ensure site level Quality Systems (Deviation, CAPA, Change Control, Complaints, Data Integrity, Quality Risk Management, and Document Control) are appropriately designed, implemented, and measured for cGMP compliance and effectiveness.

This position is also responsible for ensuring site compliance to health authority regulations and current good manufacturing practices ensuring site inspection readiness. The position leads the management of health authority (surveillance and pre-licensure) and third-party inspections and audits at the site and ensures implementation, maintenance and improvement of site self-inspection program. The position oversees the site data integrity program, quality governance, management escalations and health authority notifications.

The position will work cross functionally, across Cell Therapy sites and with global counterparts, to align and improve quality systems and processes within Cell Therapy.

Duties/Responsibilities

* Identify and implement Quality Systems, risk management principles, methods and tools and author appropriate policies, procedures, and reports and provide guidance to staff.

* Oversee and manage all areas of the Quality Systems at the site (Deviation, CAPA, Change Control, Complaints, Data Integrity, Quality Risk Management, and Document Control) to ensure they are appropriately designed, implemented, and measured for cGMP compliance and effectiveness.

* Collaborate and contribute to the writing, coordination, review, approval and maintenance of the corporate Quality Systems, Risk Management and Data Integrity Policies and associated Standard Operating Procedures (SOPs).

* Works collaboratively with above site Quality Systems functions to ensure compliance with corporate standards and policies. Facilitates the implementation of IT tools that drive effectiveness and efficiency into the business.

* Develop and maintain documentation to track key Quality System and risk management related information and provide reporting to include both quantitative and qualitative information into the Quality reporting system.

* Interface with the Global Learning Management team to ensure all site cGMP training and requirements are met.

* Ensure development, maintenance and execution of site self-inspection program.

* Ensure development, maintenance and execution of site data integrity program.

* Lead the site document and records management programs ensuring alignment with global standards and policies.

* Lead quality management review (Quality Council) for the site, ensuring proper identification and reporting of metrics measuring health of site QMS processes and report into the Pillar Quality Council

* Evaluate and report key performance metrics, analyze data and lead improvement initiatives.

* Lead and manage the site inspection readiness process to ensure the Bothell is always inspection ready. This includes preparation for routine surveillance and pre-licensure inspections.

* Drive continuous improvement for effective Quality Systems, risk management and data integrity programs and to address recurring issues identified throughout Bothell that impact the overall health of the Quality Systems.

* Lead, facilitate, coach, mentor and provide technical expertise for root cause analysis and improvement initiatives across Bothell functional areas.

* Manage health authority inspections and third party GMP audits at the site, which includes interfacing with Health Authority prior to, during, and at the conclusion of inspections.

* Lead site response and commitment process for observations received from health authority inspection and global quality audits of the site.

* Lead compilation and review of annual product quality review (APQR)

* Support authoring of new product licenses/dossiers

* Communicate significant events that may result in health authority notification, product…