Senior Manager Quality Shared Services

LOTTE BIOLOGICS USA, LLC•Syracuse, NY

2d•$91,000 - $142,000•Onsite

About The Position

The Quality Shared Services Senior Manager is responsible for oversight of the lifecycle of equipment and instrumentation supporting the Quality Control (QC) Laboratories. The Senior Manager oversees method performance monitoring, governance of the Stability Program and General Services area, and provides operational leadership of the quality systems supporting the QC laboratories. The Senior Manager is accountable for ensuring a safe, quality driven, efficient, and robust culture while continuously challenging inefficiency at every opportunity.

Requirements

Minimum B.S. degree in a scientific area with 8 to 10 years of experience, or M.S. degree with 4 years of experience.
Experience building and growing an organization into a high-performing team and influencing in a matrix environment
Proven experience in FDA (or other regulatory authority) inspection preparation and management
Demonstrated knowledge and understanding of analytical techniques and data evaluation including biologics drug substance and finished product manufacturing
Excellent problem-solving ability, attention to detail, and analytical/critical thinking skills
Strong interpersonal, oral, and written communication skills, including the ability to communicate at all levels with clarity and precision
Ability to take initiative and prioritize objectives from multiple projects, and adhere to scheduled timelines
Ability to contribute to a team based, collaborative and positive environment
Demonstrated ability to effectively train and assist other less experienced individuals
Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices
Knowledge of applicable business systems including (e.g. SAP, LabWare, Maximo)

Responsibilities

Provides ownership of Quality Control Laboratories equipment lifecycle and directs programs and procedures which assure proper qualification, calibration, operation, and maintenance
Directs operational support of the quality systems used within Quality Control Laboratories
Directs the site stability program by ensuring program schedule adherence and reporting requirements as determined by client work scope
Provides oversight of the team responsible for method performance monitoring and provides operational and technical support to ensure the effective operation of the QC Laboratories
Provides oversight of the team that is responsible for sample logistics
Provides ownership of General Services functions including media/reagent preparation, glassware washing, sterilization of laboratory supplies, and waste disposal
Ensures issues related to sample operations are escalated to proper management level
Leads a health and safety culture to maintain a safe working environment
Provides technical and strategic leadership and serves as Subject Matter Expert in cross-functional work teams
Hires, integrates, and develops high-quality team members with diverse backgrounds and talent capable of delivering against established goals and objectives
Leads by adopting continuous improvement strategies to reduce operational variance and improve laboratory efficiency
Accountable for adherence to SOPs, Policies, Directives, cGMPs, FDA, OSHA, ICH, and other regulatory agency requirements.
Ensures all personnel have adequate training, education and experience to perform their GMP related job function.
Supports regulatory inspections and audits
Creates an environment of continuous learning, improvement, and innovation and coaches the team in execution against the strategy