Director, Microbiology Quality Sterility Assurance New Brunswick - NJ - US + 3 more R1603516 Po[...]
$201.43k - $244.09kBristol-Myers Squibb
- # Director, Microbiology Quality Sterility AssuranceNew Brunswick - NJ - USFind out how well you match with this job**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.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: careers.bms.com/working-with-us.**Key Responsibilities:****Strategic Leadership & Sterility Assurance Governance*** 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* 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**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**Qualifications & Experience:** Required:• Bachelor's degree in a Scientific Discipline, preferably in:o Microbiologyo Life Scienceso Biological Sciences• Significant and progressive experience in aseptic or bioburden control manufacturing environments (production, QA, and/or validation), with demonstrated successful results in an Health Authority-regulated environment (e.g. FDA, MHRA, EMA, TGA)• *10+ years of people management experience*, with a track record of leading large, globally distributed teams• Proven experience in aseptic/sterility assurance across pharmaceutical, biopharmaceutical, medical device industries• Experience leading or supporting regulatory inspections and PAIs including direct engagement with Health Authorities (FDA, EMA, MHRA) as the senior technical SME*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.*******Compensation Overview:******Devens - MA - US: $201,430 - $244,089 Madison - Giralda - NJ - US: $188,250 - $228,114 New Brunswick - NJ - US: $188,250 - $228,114 Princeton - NJ - US: $188,250 - $228,114 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:* **Health Coverage:** Medical, pharmacy, dental, and vision care.* **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).* **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.**Work-life benefits include:**Paid Time Off* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidaysBased on eligibility\*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.***\*Eligibility Disclosure:** *T*he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.***Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as “Transforming patients’ lives through scienceTM ”, 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 a supportive culture, promoting global participation 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 Protocol**BMS has an 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.**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 View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.**Candidate Rights**BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.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: Protection**We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1603516 : Director, Microbiology Quality Sterility Assurance
- J-18808-Ljbffr Bristol-Myers Squibb
Vacancy posted 1 day ago
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