Sr. Manager, Manufacturing Records and Procedures

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 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: careers.bms.com/working-with-us

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

PURPOSE AND SCOPE OF POSITION:

This position will report to the Associate Director, Value Stream Support Operations.

The purpose of the Senior Manager, Manufacturing Records & Procedures role is to manage and provide oversight of a team of Records and Procedures Managers and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibilities are to:

• Manage deviations; facilitate e-Triage, complete Sure Event forms, provide assignments for QA assessors, lead investigations, own and present closure at IRB meetings.
• Implement appropriate CAPAs
• Author, review and approve technical and procedural documents
• Review batch records to support clinical and commercial lot release for products.

The Senior Manager, Manufacturing Records & Procedures provides leadership and guidance to their managers and technical writers while maintaining a culture of safety, compliance, innovation and continuous improvement within the Value Stream Support Operations function.

The scope of the Senior Manager, Manufacturing Records & Procedures role:

Values

• Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion

GMP

• Is accountable to ensure their Managers and their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).

Safety

• Takes personal responsibility to work safely and to ensure their managers and WCT members do the same.
• Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior.
• Operates and maintains equipment to prevent injuries or incidents.

Deviations

• Attends daily huddle and e-triage meetings to align on event and severity
• Performs reviews of drafts completed by the technical writers and provides feedback.
• Manages No Impact Events (NOE) which may require rapid turnaround or more complexity.
• Able to review and navigate through e-Triage and Sure Event Forms as well as provide assignments for QA assessors.
• Hosts weekly NOE update meetings with team and provides updates at the MO Weekly Update Meeting held by Quality.
• Takes initiative to increase process and site knowledge to facilitate understanding of QA feedback, identifies points of contact for different stakeholder groups, ensure revisions and proposed changes are compliant and coordinated with other ongoing change efforts
• Lead Manufacturing NOEs and deviation investigations to ensure on time closure

CAPA

• Able to attend update meetings with stakeholders (impacted groups, quality personnel who monitor CAPAs, etc) without intervention from managers
• Responsible for opening CAPAs as needed to revise Batch Records, SOPs, Work Instructions to support new product/process implementation, and close CAPAs
• Participate in cross-functional CAPA meetings and initiatives in S12

Documentation

• Is accountable for the documentation produced by their Records & Procedures Managers and WCT members.
• Performs batch record reviews (BRR) or Electronic Batch Record review by exception.
• Ensures that all documentation produced by their Records & Procedures Managers and WCTs follows the ALCOA+ principles.
• Ensures the documentation produced by their Records & Procedures Managers and WCT members is right first time, and all records and logbooks are complete and accurate.

Process Expertise

• Is the recognized manufacturing operations SME on the Deviations, CAPA and BRR process.
• Advanced process knowledge, familiarity with equipment, MO associate responsibilities
• Serve as a credible SME as needed during audits to present and defend deviation investigations and CAPAs
• Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations.

Resource Management

• Is responsible to provide the Production Scheduling team with information (daily, weekly monthly) on the availability of their managers and WCT resources and tracks/maintains records of all team members actual availability vs planned or unplanned absence due to holidays, sickness or other reasons.

Priorities

• Sets their managers and WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals. Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.

Training

• Ensures that their Records & Procedures Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
• Is responsible to maintain their Records & Procedures Managers and WCTs training compliance at the required 100% on-time completion rate.
• Ensures that their Records & Procedures Managers and their WCT members are proficient and qualified to perform the Records & Procedures tasks before doing so.
• Monitors team training due dates and maintains the trained status of their Records & Procedures Managers and WCT members by ensuring appropriate time is allocated to training activities.

Team Building and Development

• Is responsible to build high performing WCTs comprising of Records & Procedures Managers, Team Leads, Investigators, Technical Writers and Supervisors.
• Recruits exceptional people, conducts interviews, reviews candidates’ suitability and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process.
• Is responsible to create and maintain Workday profiles for all new hired staff.
• Is responsible to administer the annual performance review process, differentiating performance between team members.
• Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values.
• Conducts regular 1:1 meetings with each Records & Procedures Manager to mentor, develop and motivate them.
• Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities.

Budgets

• Effectively controls expenses within their influence (OT, Supplies, T&E).

Meetings

• Is responsible to facilitate and lead weekly Tier meetings with each of the Records & Procedures Managers and cross functional partners using the site standard Tier meeting tools.
• Is responsible to facilitate and lead weekly Performance Review meetings with each of the Records & Procedures Managers and cross functional partners using the site standard Performance review meeting tools and cascading KPIs/Metrics.
• Is responsible to participate in the monthly Manufacturing Performance Review meetings (facilitated by the Associate Director Value Stream Support Operations.)
• Is responsible to participate in the weekly Production Scheduling meeting to provide a summary of their WCTs training status and resource availability/constraints to be able to execute the proposed production plan in the days / week ahead.
• Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them.

DUTIES AND RESPONSIBILITIES:

• Maintain balanced and unbiased functional relationships, championing a culture of exceptional teamwork and communication across the organization.
• Identifying and where possible mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
• Develop their team through scheduled coaching sessions
• Instill proper problem identification behaviors
• Acknowledge ideas and/or issues with feedback on path forward (either yes, we will look into that or no, not now... maybe later)
• Coordinate across the value stream to align with appropriate goals and objectives
• Ability to breakdown larger goals to goals that can be influenced within their 4 walls
• Escalate issues at the appropriate level of urgency
• Participate, lead, or coach Go & See (Gemba) activities in their areas for current state understanding, process confirmation, waste reduction, increased flow, continuous improvement idea generation, coaching, or employee engagement
• Lead, coach or participate in Improvement & Coaching Kata at Tier Board Meetings, at the department’s work area, or with individual team members to creatively experiment and deliver practical improvements to gaps to target
• Support their team by removing bottlenecks to problem-solving efforts and/or escalating problems or communicating resolutions through Tiered Management process
• Communicate expectations for the usage of Improvement/Coaching Kata, Go & See
• Engaged and aligned in communicating and driving performance, issues, accountability and solving problems using the designed tiered management processes
• Recognize team and individuals for their efforts to continuously improve their processes and gaps to target conditions or to model ideal behaviors
• Create and continuously improve their Leader Standard Work for daily, weekly, quarterly, yearly critical tasks, run the business & improve the business activities
• Practice Hansei to reassess, realign, refocus teams to disconnects with desired behaviors (Accountability, Root Cause Problem Solving, Continuous Improvement, Cross Functional Collaboration, Leadership Support)
• Take personal responsibility to work safely and ensure colleagues do the same
• Be the champion for continuous improvement
• Be purposefully present in the work area
• Develop a deep ownership and understanding of one’s work area
• Establish performance measures and targets to drive improvements
• Participate in reviews of performance, generate improvement ideas and take action
• Use visual management so no problem is hidden
• Build a culture of finding root causes and take action to prevent them from recurring
• Know the value stream for the product/service you are providing to your customers
• Use actual results to identify waste, reduce variation and improve productivity

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Extensive knowledge of EHS and cGMPs and the know–how to work and manage within a regulated environment.
• Demonstrates aptitude for biotechnology principles and manufacturing systems.
• Demonstrated proficiency in selection of team and effectively managing personnel issues.
• Adaptable to a fast paced, complex and ever-changing business environment.
• Knowledge of lean manufacturing principles required. Green belt certified is a preference.
• Excellent communication skills.

Education and Experience:

• Bachelor’s degree in related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred.
• 7+ years of relevant manufacturing experience.
• Minimum of 4 years leadership experiences including the management of direct reports required.

WORKING CONDITIONS (US Only):

• Work is performed in a typical office environment, with standard office equipment available and used.
• Occasional work, meetings and investigations in a cleanroom environment that requires gowning.

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 the management.

Why You Should Apply:

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

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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 Careers
With 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. 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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.