Sr. Director, Quality Systems & Compliance

Bristol Myers Squibb • Bothell, WA

5d • Onsite

About The Position

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.

Requirements

• Extensive knowledge of Health Authority Regulations including FDA, EMA, and PMDA and rest of world (ROW) as it relates good manufacturing practices for pharmaceuticals and advanced therapeutic medicinal products (ATMPs) including ICH Q10, ICH Q9 and 21CFR Part 11.
• Strong written and verbal communication skills
• Knowledge of document and records management, and drug product labeling.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to work effectively in a fast paced environment with cross functional departments to finalize time-sensitive deliverables.
• Strong interpersonal and advanced leadership skills.
• Able to manage multiple priorities.
• Strong project planning skills.
• Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System) as well as statistical electronic tools.
• Bachelor’s degree within science discipline or related field
• 12+ years of experience within Cell Therapy, biotech or pharmaceutical industry.
• Experience interfacing with health authorities and managing health authority and third-party audits and inspections.
• Strong experience and understanding of Quality Management System structure and function.
• Experience implementing, executing and continuous improvement within deviation, change control, CAPA, quality risk management quality processes and systems.
• Experience in implementation and maintenance of document management and records management processes and systems, including electronic systems.
• Experience implementing and maintaining cGMP training program and processes including learning management systems.
• Experience leading Quality professionals and people leaders.
• Proven experience working as a detailed oriented team player with effective planning, organization and execution skills.
• Experience with health authority reporting and communications.

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 recalls, etc. to management.
• Perform health authority reporting and correspondence at the site.
• Track and verify appropriate corrective actions have been implemented, documented and align with source event.
• Ensure identification and mitigation of key quality and compliance risks at the site.
• Ensure product risk management documentation/files are maintained.
• Represent the Quality unit at various project meetings and provide quality and compliance input in the resolution of significant quality-related issues.
• Work to develop a high performing team delivering performance at a high degree of accuracy.
• Ensure adequate training of personnel in risk management processes.
• Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director