Senior Specialist Quality Systems

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.

PURPOSE AND SCOPE OF POSITION:

The Senior Specialist Quality Systems is a full-time position responsible for providing oversight and guidance for assigned quality systems and compliance activities across the Cell Therapy Development and Operation (CTDO) at Dexter Corporate Office located in Seattle, Washington.

This includes facilitating quality systems processes, in addition to serving as a key Quality Systems resource for Dexter Corporate office operations and ensuring compliance with applicable policies, procedures and regulatory requirements.

This position also works cross-functionally to ensure that quality systems processes are harmonized across CTDO facilities and relevant process improvements are identified, documented and implemented.

The role will serve as an SME and superuser for one or more Quality Systems.

REQUIRED COMPETENCIES: Education, Knowledge, Skills, and Abilities:

Education:

Degree in biology, chemistry, engineering or other related field.

Experience

7 years Quality experience with 3 years of experience within Quality Systems

Qualifications

Strong technical writing skill set and be able to critically review reports while effectively inputting and expressing Quality principles.

Innovative, proactive, and resourceful; committed to quality and continuous improvement.

Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.

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)

Previous work experience in the following: quality assurance, CAPA, change control, deviation management, compliant handling and compliance.

Experience interacting with FDA or other regulatory agencies

Must complete tasks independently, notify supervisor of decisions outside of established processes and the ability to build an internal network.

Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships within CTDO

Experience in a GxP (GLP, GMP or GCP) regulated environment

DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:

Contribute to the writing, coordination, review, approval and maintenance of the CTDO Qualitry Systems Procedures (SOPs) and Work Instructions (WP)

Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints, change controls and CAPAs

Assure the deliverables, milestones, and objectives for Quality Systems are developed to ensure success for the program(s).

Ensure that any changes or impacts to the systems are communicated and agreed to by the CTDO sites, teams and project sponsors.

Superuser role for the Quality Systems that fall under hers/his responsibility.

Develop and conduct user training for Quality Systems for Dexter Corporate Office personnel. This includes new hire and routine training for Quality System elements (i.e. Deviations, CAPAs and Change Control, Quality Risk Management,Document Control).

Support and train cross functional groups with guidance on deviation management to ensure accurate reporting, investigation, root cause analysis and corrective actions.

Perform routine and ad hoc Quality Systems metric reporting and analysis for the Dexter Dexter Corporate Office data.

Prepare metrics and perform periodic trend analysis in support of CTDO management review.

Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders.

Act as QA Subject Matter Expert (SME) to support cross functional groups for Quality Systems functions.

Act as a QA SME during internal, external and regulatory audits

Support internal, external audits and regulatory inspections. ( data gathering, interviewing or escorting auditors during the audit)

Participate in the Risk Management program, including updating risk analyses, participating in applicable teams and maintaining Risk Management documents.

Support corporate requests for compliance and regulatory assessments.

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