layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Executive Director, Microbiology Quality Sterility Assurance at Bristol Myers Squibb | LAYIQ

Strategic Leadership & Sterility Assurance Governance
Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy, ensuring alignment across all manufacturing sites, CMOs, MS&T, GTS and PD partners
Serve as the primary executive-level contact for contamination control and sterility assurance across Operations, Engineering, MS&T, and PD
Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programs
Lead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the business
Champion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmations
Own and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirements
Establish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation thresholds, trend analysis, and executive-level reporting cadence
CMO & External Partner Management
Support any implementation of BMS's Sterility Assurance Strategy
Lead CMO support in establishing and executing annual Contamination Control Strategies (CCS) and Aseptic/Sterility Assurance Roadmaps
Partner with CMOs for KPI analysis, trending, escalation, and gap assessments versus BMS standards (GQPs, QMS, FDA Guidance, etc.)
Conduct due diligence activities during onboarding of new CMOs.
Drive alignment in ways of working and standard operating procedures between all CMO partners in aseptic/sterility assurance subjects
Microbiological Quality & Technical Oversight
Provide deep technical oversight of microbiological controls across pharmaceutical, biopharmaceutical, cell therapy, radiopharmaceutical and drug product manufacturing operations
Lead the identification, qualification, and validation of terminal sterilization suppliers
Provide expert technical guidance across product design, process controls, and organizational capabilities with a focus on microbiological controls
Drive the adoption of advanced analytics, digital environmental monitoring tools, and data-driven risk assessment approaches to enhance contamination surveillance and EM trending across the network
Lead or oversee complex cross-site microbiological investigations, CAPA development, and systemic remediation efforts, ensuring robust root cause analysis and sustainable corrective actions
Regulatory & Compliance
Maintain in-depth knowledge of global regulations, guidance documents, and industry best practices related to sterility assurance, including: EU GMP, FDA, WHO, PDA, ASTM, ISPE, PhRMA , and BMS internal standards
Support review of regulatory filings related to sterility assurance and microbiology
Lead or actively support sterility assurance-related regulatory inspections globally, including direct engagement with FDA, EMA, MHRA, and other Health Authorities
Lead assessment and adoption of new or updated regulations (e.g. Annex 1)
Ensure CMOs and internal sites maintain inspection readiness at all times
Business Planning & Capital Strategy
Apply understanding of business planning, capital planning, and business case development to help drive aseptic/sterility assurance investment decisions
Balance technical, compliance, and business attributes in the decision-making process, demonstrating strong business acumen
Proactively engage and align stakeholders, capabilities, and resources to achieve company objectives
Support identification of business solutions to enhance aseptic and low-bioburden manufacturing processes, improving robustness and operational efficiency
External Advocacy
Lead or proactively influence external aseptic/sterility assurance trade associations and industry working groups (e.g., PDA, ISPE, PhRMA)
Represent BMS and proactively influence external scientific and regulatory forums, including Health Authority advisory panels and industry standard-setting bodies
Adapt and embed emerging best practices and industry innovations into BMS operations
People Leadership & Capability Development
Lead, inspire, and develop a high-performing, globally distributed team of sterility assurance and microbiology professionals
Build the newly established central MQSA function from the ground up, defining team structure, roles, operating model, and ways of working in partnership with senior leadership
Build a septic/ sterility assurance and microbiological capability across the broader BMS organization through delivery of training, coaching, and mentoring programs
Develop technical talent pipelines, supporting career growth and succession planning within the Quality function
Energize and align cross-functional teams and business partners toward a shared quality vision
Foster a culture of contamination prevention, quality ownership, and continuous learning across all sites and functions within the MQSA community of practice

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.
Supporting People with Disabilities
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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1602985 : Executive Director, Microbiology Quality Sterility Assurance

Executive Director, Microbiology Quality Sterility Assurance

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