Sr. Director, US Quality Operations

Just-Evotec Biologics (JEB) is seeking a highly motivated Sr. Director US Quality Operation focused on improving worldwide access to Biotherapeutics. 

The Sr. Director of US Quality Operations is responsible for managing and developing QA Operations at two Seattle area sites. Quality Operations includes On-the-Floor support for Manufacturing, Deviation, Change Control and CAPA management, QA oversight of QC Operations, Document Management, and Batch Disposition.

Responsibilities

• Lead a team of quality professionals with varying levels of expertise.
• Partner with Learning Management to design, implement, and improve training and education program for Quality Operations.
• Partner with senior members of Manufacturing, Tech Ops, and QC to support on-going production.
• Maintain strong relationships with multiple internal and external team members and cross functional groups.
• Ensure consistent implementation and application of the Just-Evotec Quality Management System (QMS).
• Provide input to improvement of the QMS.
• Input into planning of audits of systems and processes needed to support regulatory submissions.
• Host Client Audits and Health Authority Inspections
• Oversee investigations of quality issues, deviations, and root cause investigations. Collaborate with Manufacturing, Tech Ops, Facilities & Engineering, and QC functions to identify, assess, and determine effectiveness of CAPAs and manage and approve completion of CAPAs.
• Conduct internal compliance metrics analyses and risk assessments related to functional area responsibilities and report to management as appropriate.
• Provide input to and support for Quality Management Review.

Qualifications

• Bachelor's degree in Life/Health Sciences; Minimum 10 years of leadership experience.
• Minimum 15 years’ experience in biopharmaceutical or related industries. Experience at CDMO a plus.
• Knowledge of FDA, EMA and MHRA GMP regulations
• Excellent verbal and written communication skills.
• Knowledge of QMS and CAPA related processes and systems is required.
• Ability to work across functional areas and foster a collaborative culture of quality within the organization.
• Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors and vendors desired.

The base pay range for this position at commencement of employment is expected to be $170,000 to $250,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.