Manager, QA Engineering

4 weeks ago

Warren, United States VetJobs Full time
Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

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.

Additional Qualifications/Responsibilities

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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