Duties/Responsibilities- The AQA Manager will provide QA review and approval of technical documents and Quality Management System (QMS) records pertaining to Commercial GMP analytical methods for biologics and small molecules drug substances and drug products.
- The scope of documents will range from Commercial method validation throughout the product lifecycle of methods.
- Perform the QA review/approval of GMP documentation, including but not limited to:
- Analytical method validation and transfer for release and stability testing
- Analytical method procedures and associated change controls
- Protocols, reports and CoAs for analytical reference material and critical reagents
- Procedural and supporting documents
- undefined
- Collaborate with the relevant analytical and operational functions to determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related to qualification of analytical methods or reference standards
- o Communicate, share, and escalate issues within the AQA team for consensus resolution when appropriate
- Perform Quality approval of various QMS records, including change control management, CAPAs, standalone actions, effectiveness checks
- Assist in the development and implementation of continuous improvement initiatives for Quality and QC functions
Qualifications required:- Minimum of 5 years professional experience in Biologics and/or Small Molecule Quality Assurance, Quality Control, analytical chemistry, method development is desirable
- Previous experience in QC laboratory-facing QA activities is highly desirable
- Previous experience using electronic document and quality management systems (i.e. DCA, Veeva, PDLIMS, Trackwise) is required.
- Working knowledge of QC, QA, analytical method development or method validation functions
- Understanding and knowledge of FDA guidelines and GxP regulations.
- Excellent communication, attention to detail, relationship management, negotiation, problem-solving and personal time management skills
- Ability to manage multiple priorities with aggressive timelines
#LI-Hybrid
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Devens - MA - US: $99,380 - $120,428New Brunswick - NJ - US: $92,880 - $112,548
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
