Position Summary
The Senior Manager Quality Systems, Performance and Systems is responsible for governance, strategy, and control programs that drive end to end quality performance excellence for the Devens Cell Therapy Manufacturing site. Responsible programs include Management Review (Quality Council), Annual Product Quality Reviews (APQR), Governance Maturity across Deviation / CAPA/ Environmental Monitoring / Change Management / Risk Management / Data Integrity / Inspection Readiness Systems, and Integrated Metrics Solutions to drive Quality Performance across Operational Teams. This is an Individual Contributor position.
Responsibilities
- Coordinates and Leads Site Management Review (Quality Council) program and meeting series. Drives site performance through comprehensive quality and operational performance measurement solutions.
- Ensures site alignment with company Pillar and Enterprise Management Review programs as well as regulatory standards and industry best practices.
- Drives continuous improvement solutions with a focus on automation of site Quality performance monitoring.
- Leads the site Quality Governance Maturity program, partnering with Quality Systems Element Owners to design, deliver, and measure Quality System performance improvements.
- Oversees timely metrics reporting and ensures continuity of metrics across operational reporting forums. Delivers metrics visibility solutions to drive cross-functional accountability for site quality performance.
- Responsible for coordinating and leading site APQR for all commercial products.
- Responsible for the delivery of various Quality Improvement Projects.
- May provide oversight of site level Supplier Performance Monitoring.
- Builds strong relationships with partners in all departments.
- Partners with Compliance team to support External Inspections and Internal Audits.
Reporting Relationship
This role reports directly to the Director of Compliance & Quality Systems and maintains a dotted line reporting relationship to the Associate Director Quality Systems as a member of the site Quality Systems team.
Qualifications
- Bachelor's degree, preferably in a life science field; advanced degree preferred.
- Preferred: minimum 8 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment within biotech, cell therapy or pharmaceuticals.
- Direct experience leading and working within Quality Risk Management, Change Management, Data Integrity, Deviation and CAPA Management, and Management Review systems.
- Demonstrated ability influence without direct authority at all levels of the business.
- Demonstrated ability to drive strategic innovation, measurable process improvements, and deliver to expedited project deadlines.
- Experience with Health Authority inspections and interacting with regulatory bodies within the biotech industry.
- Strong knowledge of cGMPs and domestic regulatory requirements pertaining to Quality Systems and Quality Risk Management (ICHQ10 and ICHQ9.
- Strong interpersonal and leadership skills.
- Background in delivering business solutions using operational excellence principles.
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: $138,670 - $168,034
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 Work
Where 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.
