Director, Site Quality Head

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary:

The Director, Site Quality Head will play a critical role in the design, start-up, and oversight of Quality Operations within a multi-product monoclonal antibody drug substance manufacturing facility. This role will be part of the senior leadership team. This individual will lead the site Quality organization (QA/QC) and provide technical and strategic leadership for the manufacturing site for all quality-related matters.  Accountable to ensure compliance to GxP standards for Kyowa Kirin products, including product manufacturing, testing, and product disposition.  The site will be a new facility in the Raleigh Durham, NC area.  

Essential Functions:

•    Lead, coach, and develop an effective QA and QC team responsible for daily clinical and commercial production of monoclonal antibodies, while ensuring safe and compliant operations according to cGMP requirements.
•    Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture, test and disposition products to patients in a timely manner.
•    Participate in site early stage activities, including facility design review, facility and equipment user requirements review, defining requirements for QA computerized systems, establishing a QMS, including Standard Operating Procedures related to the QA role and responsibility and participating in the facility and equipment qualification efforts.
•    Oversee the hiring, development, and performance management of staff within QA and QC.
•    Facilitate initial discussions with the FDA with regard to design questions and coordinate a Type C Meeting.
•    Take ownership of QA Planning with regard to overall Site Readiness for Clinical / Commercial Manufacturing.
•    Develop a robust Quality Management System (QMS) that complies with global regulatory requirements.
•    Lead/ensure timely investigations of deviations or other cGMP issues at the site and communicate with site and regional leadership.
•    Assist in design and establish site QC Analytical and Microbiological testing laboratories using Lean Labs or related methodology.
•    Develop a Quality Culture and compliance related manufacturing and process controls to improve quality systems.
•    Establish critical KPIs, monitor progress and keep critical stakeholders informed of progress.
•    Lead and actively participate in all regulatory and internal inspections / audits of the facility.
•    Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site.
•    Establish key stakeholder relationships with internal and external stakeholders.
•    Prepare and manage the budget for the Quality Unit.

Requirements:

Education
Bachelor’s degree in life sciences, engineering or related field required. 

Experience
At least 10 years of Quality management level experience required in Quality Control and/or Quality Assurance functions, including experience with investigation of non-conformances and batch disposition decision making.  The candidate must also have 10 years of experience in GMP pharmaceutical manufacturing (including laboratory and/or manufacturing operations). In-depth understanding of quality assurance and quality control procedures and relevant regulatory standards, as well as experience with management of regulatory agency inspections. 

Experience with starting up and managing a new facility is a plus.  This includes facility design review, facility and equipment user requirements review, defining requirements for QA computerized systems, establishing a QMS, including Standard Operating Procedures related to the QA role and responsibility and participating in the facility and equipment qualification efforts.  

Technical Skills
Proficient in MS Office Suite. Lean Labs or Agile Lean.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age,