Site Quality Head (Sr. Director), Vector Manufacturing Facility

Company: Disability Solutions
Location: Libertyville
Posted on: October 19, 2024

Job 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: .Job Summary: This role will be responsible for leading the day-to-day Quality operations at the Vector Manufacturing Facility including Quality Assurance Operations, Quality Systems, Compliance, and Quality Control. The role will also be a key contributor to the implementation and execution of BMS's quality systems in preparation for licensure/approval of this facility for use of the manufactured vector in BMS's Cell Therapy products. This includes but not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. This individual will be a key leader in the Global Cell Therapy Vector Manufacturing Quality organization and a champion for quality principles and compliance within the Vector manufacturing Facility organization. This individual will be a member of the Site Leadership Team. This role is stationed at the Vector manufacturing facility at Libertyville, IL and reports to the Head, Cell Therapy Vector Quality in the US. Job Responsibilities:

• Responsible for the Quality oversight of GMP operations at the Vector manufacturing facility, and ensuring adherence to applicable GMP regulations and company policies and procedures
• Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and manufactured vector
• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations
• Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel
• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Patient Operations, MS&T, to ensure the timely facility qualification and readiness for licensure and approval of the facility
• Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends
• Lead the implementation of BMS's inspection readiness plan at the facility
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the facility
• Lead and host compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, etc.)
• Develop departmental goals and ensure timely completion of all deliverables
• Champion and foster a positive and quality compliance culture
• Establish and effectively manage site Quality's component of the Cell Therapy Quality annual operating budget
• Represent and lead Cell Therapy Quality in the development of corporate initiatives and planningQualifications and Education Requirements:
  • BS/MS/PhD in relevant Science or Engineering discipline and 15+ years of experience in Quality functions, and a minimum of 7 years of people management experience
  • Expertise in GMP compliance and global (e.g., US, EU, JP) regulations
  • Experience in hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory agency reviewers is required
  • Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required
  • Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
  • Background in Biologics or Cell Therapy Manufacturing is required
  • Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams is required
  • Strong technical knowledge, including practical problem-solving ability and work in highly metrics organization is required
  • Experience in continuous improvement, operational excellence and Lean six-sigma is desired
  • Demonstrated excellence in written and verbal communication
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment 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 CareersWith 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 Protocol BMS 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.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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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