Manager, QA Engineering (Analytical Lead)

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Title: Manager, QA Engineering (Analytical Lead)

Location: Warren, NJ

This role is responsible for providing quality oversight of quality control bioanalytical and microbiological safety testing for release of clinical and developmental products in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Key Responsibilities:

QA lead on quality control bioanalytical and microbiological related activities:

• Review and approve phase appropriate validation protocols/reports, stability protocols/reports, other GMP-related documentation and resolve discrepancies as needed.
• Review and approve drug product and raw material specifications.
• Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
• Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
• Interact and collaborate with cross-functional teams to achieve common goals.
• Must be knowledgeable on change control process.
• Must be knowledgeable on the process and associated methods for the assigned product.
• Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
• Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
• Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
• Complete quality oversight of documentation and processes to assure compliance with company procedures, FDA, EU, and other regulations outside of the US.
• Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
• Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
• Ensure SOPs (Standard Operating Procedures) are adequate to review and confirm appropriateness of data.

Display Leadership Qualities

• Create an environment of teamwork, open communication, and a sense of urgency
• Promote a mindset of continuous improvement, problem solving, and prevention
• Drive strong collaboration within the site and across the network

• Build trust and effective relationships with peers and stakeholders
• Drive improvements to remove inefficiencies, improve quality and optimize productivity.
• Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.

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 strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
• Must have knowledge of technology transfer for manufacturing processes. Knowledge of cell therapy manufacturing, flow cytometry and/or PCR is preferred.
• Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.
• Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
• Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.
• Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Work is self-directed.
• Must effectively communicate and interact with management and stakeholders with clarity and accuracy.
• Understands fundamental scientific problems.
• Must have strong quality background.

Working Conditions:

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 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 [email protected]. 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.

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/

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