Manager, QA Engineering (Analytical Lead)

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.

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