Senior Manager, Quality Control

Five (5) or more years of management experience leading GMP biopharmaceutical Quality Control laboratories and associated support areas, including QC Sample Management, Microbiology, Raw Materials, Chemistry/Biochemistry, Stability, Bioassay, and/or Virology.

Experience supporting the start-up and operation of a biopharmaceutical manufacturing facility is preferred.

The anticipated annual salary for this position is

$137,300 to $185,000

. The actual salary offered at the commencement of employment may vary based on several factors, including, but not limited to, relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-related knowledge, geographic location, and other business and organizational needs.

The listed salary range is just one component of the overall compensation package. At Kyowa Kirin North America, we provide a comprehensive range of benefits, including:

• 401(k) with Company Match

• Annual Bonus Program (Sales Bonus for Sales Positions)

Provide technical leadership, collaborating cross-functionally in the site's early-stage activities, including: facility detailed design review; facility, equipment, and analytical instrument user requirements review; prioritization for implementation of equipment, instruments, and analytical methods required for facility start-up (GMP Ready/OQ Complete); and ICT efforts for developing user requirements and procuring selected electronic Quality Systems for operations (LIMS/ELN/Empower).

Establish and maintain Quality Control procedures as applicable to the Site QMS Laboratory Controls Sub-system and develop training requirements for QC staff.

Lead and coordinate, cross-functionally, the robust, compliant, and timely implementation of all required analytical and microbiological test methods by ensuring completion of the required steps from method development, qualification/optimization, validation, or suitability for compendial methods and/or transfer.

Establish a Raw Materials sampling, testing, and release program in compliance with all applicable regulatory requirements (JP, USP, EP, etc.).

Coordinate testing and reporting of laboratory results in support of the facility Environmental Monitoring and Utility Monitoring programs.

Lead QC laboratory operations to achieve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.