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The Sr.
Director, Quality Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day Quality Assurance operations at the Summit West (S12) Cell Therapy (CAR T) manufacturing facility in Summit, NJ.
The position oversees QA Operations Compliance / Shop Floor oversight with cGMP, regulatory, and BMS requirements regarding the manufacturing, testing and distribution of BMS CAR T products through real time, “on-the-floor” oversight of GMP operations, oversight of material/drug product disposition, review and approval of procedures and GMP documentation.
As a senior member of the S12 Quality Leadership team, the Sr.
Director, Quality Operations, Cell Therapy Manufacturing will serve as a primary delegate and proxy for the Head of Quality, Cell Therapy Manufacturing, and is as a champion for quality principles and compliance within the organization.
This role is stationed in Summit, NJ and reports to the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.
Job Responsibilities: Responsible for QA oversight of cGMP operations at the Summit, NJ Cell Therapy manufacturing facility (S12).
Ensures operational adherence to applicable cGMP regulations, BMS policies and procedures.
Leads a site QA Operations team of 200 in the areas of Shop Floor Quality, Deviation Management, and QA Operations Compliance.
Provides direction and timely oversight to Operations, Warehouse and QC personnel during handling and resolution of real-time, “on-the-floor” cGMP events / Deviations including providing guidance to resolve compliance issues and procedural errors, ensuring immediate containment actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following deviation events.
Strategically identifies, implements and leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, MS&T, Operations, Supply Chain and Quality Control to reduce Deviations, improve right first time, improve Quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.
Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.
Ensures the required processes, procedures, systems, and resources are in place to enable a compliant disposition of materials and CAR T products.
Oversees real-time review of manufacturing batch records, logbooks and other GMP documentation for completeness and accuracy according to site procedures, cGMPs, 21 CFR, ATMPs, and other applicable health authority regulations.
Maintains a comprehensive understanding of S12 manufacturing, QC testing processes and the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.
Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor through timely, positive and constructive feedback and training.
Oversees Quality aspects of commercial distribution, logistics, launch and ramp readiness.
Oversees the Material Review Board (MRB) and evaluates recommendations made by the board during product disposition.
Collaborates with stakeholders and management to communicate lot disposition status, monitors progress and issues status reports.
Acts as subject matter expert for GMP operations during audits and regulatory inspections.
Contributes to the development and execution of the S12 inspection readiness plan.
Supports and facilitates Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time.
Serves as primary Delegate of Authority (DOA) and proxy for the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.
Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture, enhances employee satisfaction and retention, and drives a high-performing team.
Provides leadership and builds an exceptional team to manage QA functions, including hiring, mentoring and developing personnel.
Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance at the Summit S12 facility Establishes and effectively manages the Summit Cell Therapy QA Operations annual operating budget.
Qualifications and Education Requirements: BS/MS in relevant Science or Engineering discipline and 15 years of experience in managing Quality Assurance function; at minimum 7 years of people management experience Expertise in Good Manufacturing Practices (GMP) as related to Pharmaceutical, Biotech and/or ATMP Manufacturing.
Experience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial products is required Background in Biologics or Cell Therapy Manufacturing is preferred Demonstrated experience building and leading exceptional teams is required Demonstrated excellence in written and verbal communication Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships Expert-level expertise in one or more of the following: Pharmaceutical Quality Management, Project Management and/or Lean Six Sigma strongly preferred 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.
Strong presentation and visual management capability required.
Knowledge of performance measurement tools and metrics is required.
Good facilitation, change management, interpersonal and problem-solving skills required.
Experience with management of large teams (>100 people), including direct and indirect reports, strongly preferred.
Skills / Competencies: Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
Excellent influencing and negotiating experience and capabilities in a matrix environment.
Must be able to interact with senior leaders as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
Proven track record of delivering results and is action oriented.
Adapts to changing work environments, work priorities and organizational needs.
Leads within the broader internal and external network and seeks to have impact on organization-wide performance.
Embraces complexity but strives for simplicity.
Shares resources and makes difficult trade-offs to benefit the organization at large.
Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
Translates the case for change into actionable and strategic plans for the organization.
Demonstrates smart risk-taking and personal resilience when implementing change.
Enables others to navigate change with confidence and in sustainable ways.
Generates trust by maintaining the highest level of consistency between their words and their actions WORKING CONDITIONS: (US Only): A large proportion of work is performed in a typical office environment, with standard office equipment available and used, and work is generally performed seated in that environment.
Some proportion of work which may require standing and walking for >25% of the time during some intervals.
Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
Employees holding this position will be required to perform any other job-related duties as requested by management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases.
Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
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and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.
Therefore, all BMS applicants seeking a role located in the U.S.
and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.
This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana.
This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupportbms.com .
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