Manager, QA Investigations and Capa

2 weeks ago

Summit, United States Bristol-Myers Squibb Full time

**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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

As the Manager, QA Investigations and CAPA, you will be responsible for the deviation investigation approvals, and CAPA approvals and ensure adherence to applicable GMP regulations and BMS policies and procedures. Incumbent will also provide consistent direction and ensure timely completion of their deviation investigations and CAPAs to ensure success during regulatory inspections.

**Shift Available**:

- Monday - Friday, 12 p.m. - 8:30 p.m. Onsite

**Responsibilities**:

- Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
- Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
- Ensure the corrective/ preventive actions are robust and adequately address the root cause.
- May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
- Participate in monthly COP forum.
- Lead or participate on globally driven sub teams to drive investigation excellence and improvements.
- Drive deployment of effective deviation processes within representative site/function.
- Coach employees on aspects of investigations.
- Resolve investigational process or system issues.
- Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis.
- Champion for culture of quality within the deviation program.
- Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.
- Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.
- Support internal and external inspections as required.
- May present individual topics during audits as needed.
- Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
- Support integration of newer team members
- Acts as Subject Matter Expert of the deviations program and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.
- Lead meetings and represent function at cross functional and network meetings.
- Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.

**Knowledge & Skills**:

- Demonstrated experience with electronic system and databases.
- Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.
- Deviations Program Subject Matter Expert.
- Ability to work in a fast-paced team environment and lead peers through changing priorities.
- Ability to think strategically, meet deadlines and support work prioritization.
- Able to independently work across functional groups and teams to ensure requirements are met.
- Ability to motivate and foster a positive team environment.
- Confident in making decisions, able to anticipate Quality issues and proactively solve problems.
- Curiosity and ability to think critically to create innovative solutions.

**Basic Requirements**:

- Bachelor's degree in STEM field preferred. High School diploma/ Associate's degree with equivalent combination of education and work experience may be considered.
- 6+ years of experience in a regulated industry
- A minimum of 2 years of deviation experience.
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

**Preferred Requirements**:

- Quality experience.
- Leadership skills.

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This

  • Manager, QA Investigations and CAPA

    4 weeks ago

    Summit, United States Bristol-Myers Squibb Full time

    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...

  • Manager, QA Investigations and CAPA

    4 weeks ago

    Summit, United States Bristol Myers Squibb Full time

    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...

  • Head of QA Technical Operations

    2 weeks ago

    Summit, United States Bristol-Myers Squibb Full time

    **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...

  • Head of QA Technical Operations

    2 days ago

    Summit, United States Bristol Myers Squibb Full time

    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...

  • Senior Manager, QA Material Review Board

    4 weeks ago

    Summit, United States Bristol-Myers Squibb Full time

    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...

  • Senior Manager, QA Material Review Board

    3 weeks ago

    Summit, United States Bristol-Myers Squibb Full time

    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...

  • Quality - Facility

    2 months ago

    Summit, United States Katalyst HealthCares & Life Sciences Full time

    Responsibilties: Strong understanding of building systems including life-safety, lighting, mechanical, electrical, plumbing, and HVAC Strong knowledge of critical utility systems such as compressed gas, vacuum, waste Strong knowledge of and understanding of Computerized Maintenance Management Systems (CMMS) Maintains a high level of...

  • Quality - Facility & Reliability Engineer

    2 months ago

    Summit, United States Omni Inclusive Full time

    Job Summary: The purpose of the Facility and Reliability Engineer is to development and implement a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations and to maintain a qualified and compliant facility operation status. Their main responsibility will be the execution of the reliability program. The Facility &...

  • Quality - Facility & Reliability Engineer

    1 month ago

    Summit, United States Omni Inclusive Full time

    Job Summary: The purpose of the Facility and Reliability Engineer is to development and implement a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations and to maintain a qualified and compliant facility operation status. Their main responsibility will be the execution of the reliability program. The Facility &...

  • Quality - Facility & Reliability Engineer

    1 week ago

    Summit, United States Omni Inclusive Full time

    Job Summary: The purpose of the Facility and Reliability Engineer is to development and implement a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations and to maintain a qualified and compliant facility operation status. Their main responsibility will be the execution of the reliability program. The Facility &...

  • Quality - Facility & Reliability Engineer

    4 days ago

    Summit, United States Omni Inclusive Full time

    Job Summary: The purpose of the Facility and Reliability Engineer is to development and implement a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations and to maintain a qualified and compliant facility operation status. Their main responsibility will be the execution of the reliability program. The Facility &...

  • Quality - Facility & Reliability Engineer

    4 weeks ago

    Summit, United States TechDigital Corporation Full time

    Job Summary: The purpose of the Facility and Reliability Engineer is to development and implement a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations and to maintain a qualified and compliant facility operation status. Their main responsibility will be the execution of the reliability program. The Facility &...

  • Manager, Single Use System Engineer I

    3 weeks ago

    Summit, United States Bristol Myers Squibb Full time

    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...

  • Manager, Single Use System Engineer I

    3 weeks ago

    Summit, United States Bristol Myers Squibb Full time

    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...

  • Piping QA/QC

    1 month ago

    Browns Summit, United States Kodiak Labor Solutions, LLC Full time

    Piping QA/QC Client BenefitsMedical, Dental, Vision, Short-term, Long-term, Life Insurance, PTO, etc. What You Will Be DoingOur client is a well-respected full-service mechanical contractor, operating in the commercial and industrial sector. They are seeking a highly detail-oriented Piping QA/QC. The ideal candidate should be enthusiastic and highly...

  • Piping QA/QC

    3 weeks ago

    Browns Summit, United States Kodiak Labor Solutions, LLC Full time

    Piping QA/QC Client BenefitsMedical, Dental, Vision, Short-term, Long-term, Life Insurance, PTO, etc. What You Will Be DoingOur client is a well-respected full-service mechanical contractor, operating in the commercial and industrial sector. They are seeking a highly detail-oriented Piping QA/QC. The ideal candidate should be enthusiastic and highly...

  • Trial Supplies Manager

    1 month ago

    Summit, United States LanceSoft Full time

    Job Title: Quality - Trial Supplies ManagerLocation: Remote Duration: 6 months Comments: 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree. Must Haves: Phase 1 to 4 clinical trial experience. Managing end to end supply chain. Job Description: 100% Remote This position is responsible for the...

  • Trial Supplies Manager

    1 month ago

    Summit, United States Ivory Systems Full time

    This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.• Collaborating...

  • Trial Supplies Manager

    2 months ago

    Summit, United States Ivory Systems Full time

    This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.• Collaborating...

  • Trial Supplies Manager

    2 months ago

    Summit, United States Ivory Systems Full time

    This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4.The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.• Collaborating...