Manager, Compliance and Quality Systems

1 month ago

Ayer, United States Bristol Myers Squibb Company 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.

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 .

The Manager, Compliance and Quality Systems maintains responsibility for all routine Compliance and Quality Systems activities at the Devens Biologics site. This includes the execution of annual product reviews, internal audits, regulatory observation and intelligence activities, and support of commercial and clinical change management and inspection management.

KNOWLEDGE AND SKILLS :

Required: A minimum of 8 or more years of relevant experience in a biologics or pharmaceutical manufacturing environment is required. Prior GMP compliance / Quality Systems experience is preferred.Knowledge of science or engineering generally attained through studies resulting in a Bachelor's degree in a scientific or technical discipline.Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required.Excellent computer skills and proficiency with MS Office is required. Advanced knowledge of Excel preferred.Basic understanding of manufacturing processes, drawings and specifications and quality systems, including knowledge of applicable U.S. and E.U. cGMP regulations/guidance pertaining to change control required.Candidate must be familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMA, Health Canada, etc.Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, with demonstrated knowledge of subject matter related to quality and compliance. Preferred Previous work experience with TrackWise/Veeva and responsibilities related to metrics and data analysis preferred.Experience in high-risk investigations and/or change controls is highly desirable MAJOR RESPONSIBILITIES : Local process owner for one or more of the following at the Devens site: Annual Product Quality Review (APQR), Self-Inspections, Global Regulatory Evaluations (GROe), and Change Management; with responsibility to ensure site alignment with global policies and procedures.Maintains related site procedures and drives opportunities for continuous improvement in support of enhanced quality system performance.Manages program metrics process by developing applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs. Develops appropriate action plans as needed to remediate or continually improve on quality system performance.Presents related metrics to site Quality and operations management.Leads completion of APQR reports including project management, compilation of report sections, and driving review/approval by established timelines.Supports the Devens self-inspection program as a lead auditor. Develops, plans, and conducts audits, writes audit reports, reviews finding response, and tracks corrective actions and audit closures. Provides support to the site Quality Management to ensure site compliance with applicable regulatory, cGMP and BMS requirements.Reviews and assesses more complex policy/procedure revisions, network regulatory observations, and compendia updates against site processes, procedures and methods.Leads remediation plans for major impact or complex observations.Ensures all commitments are tracked for timely completion.Manages Devens change control system as site SME and representative on global changes (manages impact assessor assignments, ensures compliance to established procedures, facilitates movement of records through the process).Facilitates Local Change Review Board (LCRB), assures consistent, effective use of the site change control system for all change requests.Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements.Provides compliance and quality support to site Quality Risk Assessments through participation in formal risk assessments and review and approval of reports, as delegate of Quality Risk Management (QRM) LPO.Supports the Site Inspection Readiness Program by conducting prep sessions with SMEs and mock inspections.Core inspection team member. Executes targeted inspection preparation activities. Leads SME preparation room / back room during inspections or supports front room activities.Generates Quality System queries and reports as needed during inspections.Conducts user training on internal audits and inspection readiness as needed.#BMSBL

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

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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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.

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

  • Manager, Compliance and Quality Systems

    1 month ago

    Ayer, Massachusetts, United States Bristol Myers Squibb Company 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 Engineer

    2 months ago

    Ayer, United States randolph and baldwin Full time

    BUSINESS OVERVIEW:Randolph & Baldwin, Inc. is a manufacturing and engineering company specializing in Defense Systems and Ocean Systems. We manufacture a diverse range of parts from small, machined components to electrical chassis assemblies to extremely large weldments. Our manufacturing capabilities involve tight tolerancing and manufacturing processes at...

  • Quality Engineer

    2 months ago

    Ayer, United States randolph and baldwin Full time

    BUSINESS OVERVIEW:Randolph & Baldwin, Inc. is a manufacturing and engineering company specializing in Defense Systems and Ocean Systems. We manufacture a diverse range of parts from small, machined components to electrical chassis assemblies to extremely large weldments. Our manufacturing capabilities involve tight tolerancing and manufacturing processes at...

  • Quality Assurance Manager

    3 months ago

    Ayer, United States Nasoya Foods USA, LLC. Full time

    Job DescriptionJob DescriptionNasoya has introduced millions of Americans to our versatile plant protein and grown to be the country’s #1 brand of tofu. Our product line-up has grown too. Today, Nasoya offers more than 10 different varieties of tofu, including ready-to-serve items like TofuBaked and Toss’ables, pre-marinated and pre-baked to eliminate...

  • Engineer - IT Compliance, Cell Therapy Devens

    2 weeks ago

    Ayer, United States Bristol Myers Squibb Company 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 Assurance Specialist

    2 hours ago

    Ayer, Massachusetts, United States SPECTRAFORCE Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at SPECTRAFORCE. As a Quality Assurance Specialist, you will be responsible for supporting the incoming inspection and disposition of materials at our facility.Key ResponsibilitiesInspect incoming materials such as consumables, packaging, and raw materials to ensure...

  • Quality Assurance Specialist

    1 hour ago

    Ayer, Massachusetts, United States SPECTRAFORCE Full time

    Job Summary:The Quality Assurance Specialist will support the incoming inspection and disposition of materials at the Devens facility. This role will perform visual inspections and review documentation to ensure compliance with client policies and standard operating procedures.Key Responsibilities:Perform incoming inspections of materials, including...

  • Quality Assurance Supervisor

    1 week ago

    Ayer, Massachusetts, United States Nasoya Foods USA, LLC. Full time

    Job OverviewAt Nasoya Foods USA, LLC, we pride ourselves on being the leading brand of tofu in the United States, introducing millions to the benefits of plant-based protein. Our diverse product range includes over 10 varieties of tofu, designed to cater to the needs of consumers looking for convenient and nutritious options.Key ResponsibilitiesThe Quality...

  • Quality Assurance Team Leader

    3 days ago

    Ayer, Massachusetts, United States Nasoya Foods USA, LLC. Full time

    Job OverviewAt Nasoya Foods USA, LLC, we pride ourselves on being the leading brand in plant-based protein, particularly tofu. Our extensive range includes over 10 varieties, designed to cater to diverse culinary needs. We are currently seeking a dedicated Quality Assurance Supervisor to oversee our quality assurance initiatives and ensure the highest...

  • Quality Specialist II

    3 months ago

    Ayer, United States Sealed Air Corporation Full time

    Specific Responsibilities Include:   Inspects materials and products, for conformance to specifications, using fixed or preset measuring instruments. Ensures materials and products are in accordance with established tolerance levels for quality and performance. Performs incoming visual/dimensional (V&M) inspections, in process and final...

  • Quality Assurance Supervisor

    3 months ago

    Ayer, United States Nasoya Foods USA, LLC. Full time

    Job DescriptionJob DescriptionNasoya has introduced millions of Americans to our versatile plant protein and grown to be the country’s #1 brand of tofu. Our product line-up has grown too. Today, Nasoya offers more than 10 different varieties of tofu, including ready-to-serve items like TofuBaked and Toss’ables, pre-marinated and pre-baked to eliminate...

  • Quality Control Inspector

    1 day ago

    Ayer, United States SPECTRAFORCE Full time

    Position Title: QA Incoming Inspection and Material Disposition AssociateDuration: 6 MonthsWork Schedule: Monday - Friday, Business HoursLocation: Devens , MA , 01434Must Haves:- Minimum of 1 year working in a GMP environment- Experience using SAP- Minimum 1 year experience performing visual inspection- Experience performing review or verification...

  • Quality Control Inspector

    1 week ago

    Ayer, United States SPECTRAFORCE Full time

    Position Title: QA Incoming Inspection and Material Disposition AssociateDuration: 6 MonthsWork Schedule: Monday - Friday, Business HoursLocation: Devens , MA , 01434Must Haves:- Minimum of 1 year working in a GMP environment- Experience using SAP- Minimum 1 year experience performing visual inspection- Experience performing review or verification...

  • Sr. Manager, Supplier Governance

    1 month ago

    Ayer, Massachusetts, United States Bristol Myers Squibb Company 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 Technician 3rd shift

    2 months ago

    Ayer, United States Advantage Technical Full time

    We are seeking a Quality Technician for 3rd shift, for our Client who is a leader in Manufacturing along the 495 route 2 highway. Fortune 500 company that offer unprecedented benefits and room for growth. If you are seeking a career opportunity then apply with us today to learn more We are seeking candidates who can perform the following Operate and monitor...

  • Specialist, Shop Floor Quality Assurance

    3 months ago

    Ayer, United States Bristol Myers Squibb Company 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...

  • Metal Fabrication Specialist

    1 week ago

    Ayer, Massachusetts, United States randolph and baldwin Full time

    JOB DESCRIPTION:Position: Welder/FabricatorBUSINESS OVERVIEW:Randolph & Baldwin, Inc. is a premier manufacturing and engineering firm focused on advanced Defense Systems and innovative Ocean Systems. Our expertise lies in producing a wide array of components, ranging from intricate machined parts to substantial welded assemblies. We pride ourselves on...

  • Lead Manager, Facilities and Equipment Validation

    1 week ago

    Ayer, Massachusetts, United States BioSpace, Inc. Full time

    Position Overview About Us At BioSpace, Inc., we believe in the power of innovation and collaboration. Our work is not just about meeting expectations; it’s about exceeding them and making a significant impact in the lives of patients. Here, you will engage in challenging and meaningful projects that contribute to groundbreaking advancements in the...

  • Metal Fabrication Specialist

    1 week ago

    Ayer, Massachusetts, United States randolph and baldwin Full time

    JOB DESCRIPTION:Position: Metal Fabrication SpecialistLOCATION: USA - Ayer, MassachusettsCOMPANY OVERVIEW:Randolph & Baldwin, Inc. is a prominent manufacturing and engineering firm focused on Defense Systems and Ocean Systems. Our expertise encompasses a wide array of components, ranging from intricate machined parts to substantial welded assemblies. We...

  • QA Inspection and Material Disposition Associate

    1 week ago

    Ayer, United States Sunrise Systems, Inc. Full time

    Sunrise System Inc. is currently looking for QA Incoming Inspection and Material Disposition Associate at Devens, MA, Onsite with one of our top pharma clientJob Title: QA Incoming Inspection and Material Disposition AssociateLocation: Devens, MA, OnsiteDuration: 6 months (Possible extension)Position Type: Hourly contract Position (W2 only)Job...