Jobid=627646590519085868 (0.0996)
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.
Position Summary
The Senior Specialist, Quality Systems and Compliance, is responsible for supporting the ownership and oversight of Quality Systems, per established local and global standards. This position supports the overall compliance and performance of the Quality Systems processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities.
This role also involves coordinating pre-inspection activities, streamlining information from various groups at both the site and global levels, and maintaining inspection readiness material content.
Duties/Responsibilities
Support the administration and maintenance of the Quality Systems, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation.
Supports, maintains and specializes in QMS systems and processes as applicable , such as Risk Management, E-Logbooks, Document and Records Management, Annual Product Quality Review and Quality Council.
Coordinate pre-inspection activities, including streamlining information needed from other groups at the site, and above-site (Global) level.
Support the site to prepare and execute corporate audits and Health Authority inspections for multiple markets.
Share data/ knowledge within and across site and network and participate in community of practices.
Build & maintain strong relationships with partner functions.
Lead meetings and represent function at cross functional and network meetings.
Identify improvement opportunities and drive team continuous improvement goals and projects related to the Quality Systems in scope for the site.
May act as subject matter expert and present Quality Systems overviews and related topics during audits and inspections.
Maintain compliance with assigned learning plan.
Support integration of newer team members
Supports Data Integrity Site Representative.
Perform any duties requested by management, after completing required training (if applicable).
Reporting Relationship
Senior Specialist, Quality Systems and Compliance reports into the Associate Director Quality Systems and Compliance.
Qualifications
Specific Knowledge, Skills, Abilities:
Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed actions.
Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
Ability to work in a fast-paced team environment and changing priorities.
Detail oriented and task focused with ability to meet deadlines and prioritize work.
Able to work across functional groups and teams to ensure requirements are met.
Self-motivated and contribute to a positive team environment.
Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
Curious and ability to think critically to create innovative solutions.
Education/Experience/ Licenses/Certifications:
– Bachelor's degree preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
– 4+ years of experience in a regulated industry, preferably with 1+ year of quality system experience.
– Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
– Demonstrated proficiency with electronic system and databases.
Deel deze vacature: