Position Summary

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.

Duties & 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

Education & Experience

• 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

Knowledge, Skills, Abilities

• 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)

Physical Demands

This position is primarily an office-based position requiring sitting and repetitive use of arms/hands/wrists, especially when working with a computer. This role may require donning of appropriate levels of personal protective equipment (PPE) for entry into laboratory spaces. Walking within and between buildings is required to enter laboratories and collaborate with others. Lifting (not to exceed 50 lbs), bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching may be required.

Work Environment

This position is an office based role with occasional exposure to laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, hazardous chemical reagents, and biohazardous materials (e.g. live cell cultures).

Supervisory Responsibilities 

• Direct supervision of up to 6 personnel
• Provide feedback, coaching, and performance evaluations to each direct report.

Travel

<5% Travel Required

Target Bonus

16%

Work Location:

East Syracuse, NY