Director/Sr. Director of Product Quality

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

The Director of Product Quality is responsible for overseeing technical aspects of Quality for products manufactured as Just-Evotec Biologics (JEB). Manage Quality activities and deliverables for New Product Introduction (NPI) and/or technical transfer into JEB facilities. Utilize experience, regulatory knowledge, and technical expertise to ensure quality throughout the product lifecycle.

Responsibilities

• Develop overall Product Quality program. Establish roles and responsibilities in conjunction with other Sr. QA leaders.
• Hire and lead a team of quality professionals with varying levels of expertise.
• Communicate with internal Quality partners to ensure timely completion of NPI deliverables.
• Act as single point of contact for Quality issues with client Quality organizations.
• Maintain strong relationships with multiple internal and external team members and cross functional groups.
• Support the development and/or improvement of SOPs related to NPI and Tech Transfer activities.
• Communicate product related quality issues to senior management.
• Perform quality document review and approval as required.
• Oversee investigations of product related quality issues, deviations, and root cause investigations.
• Provide input to and support for Quality Management Review.
• Travel to JEB local and international sites as required.

Qualifications

• Bachelor's degree Life/Health Sciences; Minimum 5 years of leadership experience.
• Minimum 10 years’ experience in biopharmaceutical or related industries in manufacturing, Product Development or MSAT, QC or QA . Experience at CDMO a plus.
• Knowledge of FDA, EMA and MHRA regulations and guidelines. Experience with biosimilar filings a plus.
• 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 is strongly desired.

The base pay range for this position at commencement of employment is expected to be $160,000-$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.