Manager, QA Engineering

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Title: Manager, QA Engineering

Location : Warren, New Jersey

The Manager, QA Engineering is responsible for ensuring quality, integrity, and review of validation and qualification documents for all equipment and GMP facility activities.

The roles and responsibilities are divided into 2 parts:

70% of the workload : Responsible for the approval of all facility and utility related plans and qualification documents with a focus on compliance with regulatory and BMS policy.

30% of the workload : Functional responsibilities include providing QA oversight of the site aseptic program including contamination control strategy, gowning, environmental monitoring, aseptic process validations / media simulations, quality culture, cleaning and disinfectants with applicable procedures.

This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Key Responsibilities:

Ensuring accurate and timely maintenance of validation and qualification documents for all facility activities and design; investigations and evaluation of change control and supports Quality Risk Management program activities at the site.

Assures appropriateness of validation plans, qualification protocols, associated reports and procedures.

Support ECQ and Facilities related investigations in ensuring appropriate and thorough impact assessment, root cause analysis and corrective/preventive actions are documented and implemented.

Ensures compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.

Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.

Provide Quality guidance on the environmental monitoring program including EM risk assessments, EM Performance Qualifications, Re-qualifications, etc.

Provide input to the gowning, aseptic training, aseptic techniques and behaviors, aseptic process validations / media simulations, aseptic risk assessment.

Sponsor and support the change initiatives and the implementation of process improvement initiatives.

Ensure site is compliant with global and regulatory data governance and data integrity requirements.

Support any other goals and objectives of the site Quality Assurance organization, as needed.

Qualifications & Experience:

B.S. degree required.

Minimum of six years of experience in the pharmaceutical or related industry.

Equivalent combination of education and experience acceptable.

Must have knowledge and experience with cGMP, manufacturing, Quality and compliance, aseptic techniques and behaviors.

Strong understanding of critical building & utility systems including life-safety, lighting, mechanical, electrical, plumbing, clean rooms, compressed gases, security, and site access.

Strong knowledge of facility management systems, building automation, and computerized maintenance management systems (CMMS).

General understanding of critical utility systems such as compressed gas, vacuum, and HVAC

Knowledge of FDA & GMP regulations, IBC/IFC building codes, OSHA, NFP, FM, LPDS and UL.

Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other facility qualification documentation.

Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva).

Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.

Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.

Intermediate knowledge of quality systems including CAPA, change control, and document management systems.

Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.

Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.

Consults management for advice on complex issues.

Able to prepare written communications and communicate problems to management with clarity and accuracy.

Drive strong collaboration within the site and across the network.

This is an Onsite position and operating at regular business hours.

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. 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.

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If you come across a role that intrigues you but doesnt 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/ (https://careers.bms.com/eeo-accessibility) 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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

Company: Bristol-Myers Squibb

Req Number: R1585969

Updated: 2024-10-01 03:05:23.620 UTC

Location: Warren-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.