QA Operations Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

BMS is seeking a QA Specialist within the Global Cell Therapy Quality Unit to partner with and support the Global Patient Operations department (including Patient Scheduling & Cell Logistics, Apheresis Network Operations, Patient Planning & Reporting, and Business Systems & Integrations).

This team’s goals include ensuring a consistent and global approach to operational oversight of Apheresis Network Onboarding and Maintenance as well as cellular and logistical troubleshooting within this scope.

Job Description

Support development, review and approval of Global Patient Operations processes and procedures in support of Scheduling, Apheresis Onboarding, Distribution and CDP On-Site Storage

Support Quality Pt Ops liaison(s) to manufacturing process/personnel and associated apheresis and final drug product troubleshooting; provide real-time quality event support

Serve on project teams by providing quality assurance guidance and input regarding quality systems application and execution in support of project activities.

Provide Quality representation and direction to Patient Operations and technical teams, as required.

Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the lifecycle of autologous cell therapies.

Collaborate with Rest of World teams in order to ensure consistent application of global procedures and processes.

Provide Quality review and approval of training materials, internal and external procedures, apheresis accounts (JAMS), risk assessments, and commercial readiness documentation in support of Apheresis Network onboarding and maintenance.

Support Customer Experience Playbook and Call Trees

Provide Global Patient Services (GPS) system general support, data configuration approvals, SOP review and approval

Quality Operations and Systems Support including deviation management, change management, complaints, CAPA, compliance guidance (issue management)

Support Key Performance Indicating metrics to ensure continuous improvement

Review and negotiate apheresis site Quality Agreements, as required

Support North America team for on-site product storage assessments

Interface with regional clinical specialists and Commercial Launch Excellence Managers

Assist with compliance and other regulatory inspections and in developing remediation efforts and responses. Recognize opportunity for improvement, driving CAPA and/or change control.

Model effective and constructive communication behaviors and interactions with technical departments both orally and in writing.

Support other Quality initiatives as directed by management.

Required Qualifications

Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering or closely related areas.

Minimum of 3 years experience in Quality Assurance or Quality Operations supporting cellular therapy, with 5 years FDA-regulated industry experience.

Strong organizational skills, including ability to follow assignments through to completion.

Advanced skills in leading, influencing, and negotiating.

Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues.

Independent decision making capability and ability to think conceptually and understand impact of decisions.

Excellent verbal and written communication skills.

Proven leadership and mentoring skills for junior staff.

Preferred Qualifications

Experience with Commercial products.

Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.

Ability to prioritize and successfully manage complex and competing projects.

Detail-oriented with expertise in problem solving and solid decision making abilities.

Ability to work in a fast paced environment

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com