Manager, Quality Control
Employment Type: Full-Time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. PURPOSE AND SCOPE OF POSITION:
The QC Manager is a key member of the QC leadership team responsible for the design, implementation, management, and continuous improvement of processes/systems designed to ensure high throughput and production of cell therapy products in accordance with cGMP regulatory requirements, corporate policies and industry best practices. The principal functions of this position are to provide leadership to the QC Operation department; overseeing of cGMP analytical testing and raw material testing in order to ensure product safety; lead cross-functional teams in support of product development, and technology transfer. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Education:
- BS/MS in s cientific discipline
Knowledge, Skills, and Abilities
- 10+ years of experience in a regulated industry
- Minimum of 5+ years of leadership experiences including the management of direct reports required.
DUTIES AND RESPONSIBILITIES: Key Responsibilities
- Strong working knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Demonstrated experience building and leading exceptional teams
- Ability to apply Lean, Six Sigma and Risk Management concepts and tools is preferred.
- Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
- Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
- Demonstrated success working in a high-performing, business results-driven environment.
- Background in Protein Biologics Manufacturing is required and experience in Cell Therapy Manufacturing is desired.
- Experience in regulatory agency inspections is required.
- Action and detail oriented, strong knowledge in quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines) required.
- Manage QC operations in support of drug product release including method transfer, product stability, and raw materials release testing.
- Organize and manage cross functional relationships with Manufacturing, Lot Disposition, Document Control, QA Operations, and QC Microbiology teams.
- Responsible for the hiring, mentoring, and development of staff. Manages and ensures the setting of goals, training and development of staff.
- Assertive in work interactions, leading by example and building collaborative relationships.
- Builds a strong team that is reliable, responsive and flexible to shifting demands.
- Develop, implement, approve and enforce QC Operation procedures and policies consistent with global systems, and cGMP manuals.
- Review and trend investigations of aberrant events, system suitability failures, laboratory deviations, and OOS test results.
- Identifies and mitigates risks in QC labs that could negatively impact the safety, identity, strength purity or quality of the product.
- Assists in the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
- Provides leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product.
- Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
- Ability to effectively represent the company during interactions with FDA and other regulatory officials, demonstrating credible and substantial QC laboratory expertise.
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 the resources to pursue their goals, both at work and in their personal lives.
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