- Monday - Friday, Hybrid roleResponsibilities:
- Directs quality oversight of compliance and quality systems activities including Quality Risk Management, Data Integrity, Training, Audits and Inspections, Document and Records Management and Site Quality Council.
- Leads the local process owners for Quality Systems (deviation, capa, change control, data integrity, training, risk management, and audits).
- Ensures that all Compliance & Quality Systems personnel have adequate training, education and experience to perform their GMP related job function effectively.
- Leads and facilitates Health Authority inspection approvals of the facility and products.
- Leads the site self-inspection program to ensure that the site meets current regulatory and BMS corporate requirements.
- Provides training programs for auditing and various GMP compliance topics.
- Manages responses and leads efforts for all CAPA/lessons learned from audits and inspections.
- Provides leadership, guidance and problem-solving skills.
- Manages the Quality Council by sponsoring and driving Quality initiatives that directly impact the Site operations.
- Oversees all quality metrics tracking.
- Manages the site Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.
- Ensures compliance with regulatory commitments.
- Ensures compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.Knowledge & Skills:
- Proven record with the successful implementation and management of the Quality System in a sterile, biologics or cell therapy commercial manufacturing facility.
- Expertise in GMP compliance, Quality System and global GMP regulations; must also have strong knowledge and experience with Quality Risk Management.
- Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and timely mitigate unfavorable quality compliance trends.
- Demonstrated experience building and leading exceptional Quality 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.
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment.Basic Requirements:
- BS/MS in relevant Science or Engineering discipline
- Minimum of 7 years of experience with being Manager of Managers (tiered leadership).
- Minimum of 10 years of experience with biologics health authority inspections experience.
- Minimum of 5 years of experience with leading health authority inspections.
- Minimum of 10 years of experience within a Quality System and Compliance or equivalent Quality roles.#BMSCART, #LI-Hybrid
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 scienceTM , 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 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. -
Quality Systems Manager
2 hours ago
GRIFOLS, S.A. Akron, United StatesWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...
-
Quality Systems Manager
1 day ago
GRIFOLS, S.A. Akron, United StatesWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the worl ...
-
Quality Systems Manager
4 days ago
GRIFOLS, S.A. OH-Akron, United States· Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the w ...
-
Senior Quality Systems Engineer
1 week ago
Schaeffler Technologies AG & Co. KG Akron, United StatesSelect how often (in days) to receive an alert: · Create Alert · Schaeffler is a dynamic global technology company and its success has been a result of its entrepreneurial spirit and long history of private ownership. As a partner to all of the major automobile manufacturers, as ...
-
Manager, QA Investigations and Capa
2 weeks ago
Bristol-Myers Squibb Summit, United States**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 ...
-
Atlantic Health System Summit, United States**Atlantic Health System is Seeking a Chairperson for the Department of Obstetrics and Gynecology in Summit, New Jersey** · Atlantic Health System, one of the largest non-profit healthcare networks in New Jersey, is seeking a physician to lead the Department of Obstetrics and Gyn ...
-
Administrative Assistant Pt Days Wound Healing
2 weeks ago
Atlantic Health System Summit, United StatesAssists with the organization and creates dynamic presentation of clinical and operational data. · - Works closely with management to share information, improve the quality of our services and solve problems in the field. Assists in the marketing of services. · - Initiates and pa ...
-
Registrar, Pd Days Healthstart Clinic
3 weeks ago
Atlantic Health System Summit, United StatesThe primary function of the Admitting Representative position is to greet and register patients in a courteous and professional manner, verify insurance benefits, secure patient signatures for required hospital forms and collection of patient's financial responsibility when requi ...
-
Sterile Processing Technician
3 weeks ago
Atlantic Health System Summit, United StatesResponsible for the sterilization and cleaning of medical equipment, instruments, and supplies. Responsible for cleaning/disinfecting contaminated supplies, delivering sterile supplies, maintaining inventory, and the processing of reusable medical devices for surgeries, examinati ...
-
Industrial Maintenance Technician
3 weeks ago
Owens Corning Summit, United States**Job Title: Maintenance Spec 1C A Prob** · **Pay Rate**: Probation rate $32.46 after 60 days $32.96 · **OT**: Overtime available · **Job Type**: Full time · **Benefits** · - Dental, Vision and medical insurance starting day 1 of employment · - $.75 shift differential for second ...
-
Associate Director, Cell Therapy Procurement
2 weeks ago
Bristol-Myers Squibb Summit, United States**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 ...
-
Chief Front-end Architect
2 weeks ago
iSeatz Summit, United States**Our Mission**: · iSeatz provides digital commerce and loyalty tech solutions that enable travel and lifestyle bookings to global customers including American Express, Expedia, and IHG Hotels. Our proprietary platform processes more than $4B a year in transactions. We have a his ...
-
Quality Systems Engineer
4 weeks ago
ITS - Integrated Talent Strategies Streetsboro, OH, United StatesIntegrated Talent Strategies (ITS) is seeking a EHS Specialist to work in the Streetsboro, OH area. Development, implementation and maintenance of a system for hazard identification and risk assessment on existing and new processes and equipment · Coordinate and support the clos ...
-
Training as a hearing aid acoustician in
3 weeks ago
Horizon Ventures Summit, United StatesWe are offering apprenticeships in full-time in the Greater Hamburg area and Pinneberg district. · In 1979, the Zacho family had a vision. We wanted to provide a different kind of service to people with hearing impairments than any other acousticians at that time. Our goal was to ...
-
Locksmith (m/f/d) Maintenance
3 weeks ago
Horizon Innovations Akron, United StatesThe Lankwitzer Lackfabrik GmbH is a successful family-owned company that supplies renowned industrial customers worldwide with high-quality coating systems. Thanks to our many years of expertise, we offer our customers first-class and customized solutions in the premium segment. ...
-
Assembly Manager
1 week ago
Velocity Ventures Akron, OH, United States FreelanceLooking for a job that protects lives and values? Look no further Minimax is one of the leading companies in fire protection and is known worldwide for its innovative technologies and excellent research. As a Montage Master (m/f/d), you will have both organizational and technical ...
-
Healthcare and nursing assistant
6 days ago
BlueWave Solutions Summit, United StatesSummit is currently seeking a highly motivated and skilled individual to join our team as a Registered Nurse. As a member of our team, you will have the opportunity to work in a dynamic and diverse environment, with a focus on providing high-quality care to our patients. We offer ...
-
Nursing specialist in elderly care
6 days ago
BlueHorizon Solutions Akron, United StatesAbout Ev. Johanneswerk gGmbH: · At Ev. Johanneswerk, we all work together for a common good: we care for and support people in need. Around 7,300 employees contribute to this in over 70 facilities for elderly care, integration assistance, as well as in our clinics and daycares. · ...
-
Bristol-Myers Squibb Summit, United States**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 ...
-
Associate Mako Product Specialist
1 day ago
Stryker Corporation Summit, United States**Why join Stryker?** · **Who we want** · - **Relationship-builders.** Thoughtful product specialists who create genuine, trusting relationships with surgeons, hospital staff, internal team members and potential new customers. · - **Team players**. Collaborative partners who are ...
Sr Director, Quality Systems - Summit, United States - Bristol Myers Squibb
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: .
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.
This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures. This individual will be responsible for leading the continuous inspection readiness efforts and the site's self-inspection program.
Shift Available:
