Manager Quality Operations

Manager Quality Operations / Team Leader

The Manager Quality Operations / Team Leader will be responsible for planning, organizing, supporting and supervising Quality Operations personnel working with the following areas : Floor Support; Lot Release; Regulatory / GMP Inspections; Deviation investigations; Change Control, and other related compliance activities. The manager will be responsible for development and reporting of various metrics to assure that management in Operations and QO are aware of the status of compliance. The manager will be accountable for the efficiency, accuracy and service levels of unit personnel and is expected to support daily operations and budget. The manager will also be expected to initiate and lead improvement projects. The manager is expected to learn and manage other responsibilities as assigned. The manager may also be responsible for being a primary contact for the escort and facilitation of visits by outside regulatory agencies and other related GMP / ISO compliance inspectors.

Position Responsibilities

• Reporting to the Site Quality Lead, the Quality Operations Manager will oversee a staff of salary and over time eligible colleagues involved in the areas of :
• Quality Operations Specialists
• Lot release specialists
• Other related compliance activities
• Responsible for the development and report out of various metrics to ensure management in Operations & QO are aware of the status of compliance.
• Accountable for the efficiency, accuracy and service levels of unit personnel and is expected to support daily operations and budget.
• Expected to initiate & lead continuous improvement projects.
• Expected to learn and manage other responsibilities, as assigned.

Technical Skills Requirements

Education and Experience

Physical Requirements

The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the colleague is regularly exposed to both office settings and a manufacturing environment, including moving mechanical parts. The work conditions for this position are 70% stationary and 30% standing and walking throughout the workday. The colleague will be required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety ("steel-toed") shoes, eye protection, gloves, and protective clothing.