- Responsible for establishing, expanding, and maintaining RayzeBio GMP compliance program at RayzeBio Indianapolis.
- Oversee and coordinate quality issues cross-functionally
- Implements Quality Systems at RayzeBio including implementation of electronic systems as needed.
- Maintain and Provide Oversight of Quality Assurance Systems including: Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; and GxP Training
- Manage internal audit program, audit schedule, and approved vendor list. May perform both internal and external audits.
- Evaluate, author, and/or review operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS).
- Assist in developing reports quality/KPI metrics to support GxP activities and management review.
- Supervise 1-3 direct reports
- Bachelor's degree or higher
- Minimum 5-7 years in GxP (GMP, GLP, GCP) pharmaceutical or other regulated environment demonstrating progressive increase in responsibility. Highly desirable to have a minimum of 6 years of Quality Systems experience.
- Solid understanding of US and European regulations including application in the day to day environment
- Ability to successfully solve challenging issues, critical thinking, and detail oriented
- Strong interpersonal, verbal, and written communication skills
- Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
- Excellent written and verbal communication skills.
- Previous experience implementing and developing quality systems preferred
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Manager, Quality Assurance Systems - Pineville, United States - Bristol-Myers Squibb
Description
Working with UsChallenging. 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 rich in diversity.
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:
Location:
Indianapolis
Background
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA.
Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes.
RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS.
RayzeBio is developing innovative drugs against targets of solid tumors.The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer.
Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.Summary
This position is responsible for the tactical oversight and maintenance of the Quality Management System for RayzeBio internal and external operations.
This includes establishment, continuous improvement, and ensuring the consistent implementation of global quality system policies in the GMP spectrum. This position will report to the Head of GMP Quality and oversee GMP quality systems at RayzeBio Indianapolis.Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Education and Experience:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
Work EnvironmentThe noise level in the work environment is usually moderate.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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