Sr. Director Global Quality Management Systems

Just-Evotec Biologics (JEB) is seeking a highly motivated Sr. Director Global QMS that desires a significant opportunity to improve worldwide access to biotherapeutics. Remote with travel.

The Sr. Director Global Quality Management Systems (GQMS) reports to the Global Head Quality Systems. The primary focus of this role is to build and manage a Global Quality Management System (GQMS) that complies with US and EU regulations, laws and guidance’s. Partner with JEB leaders to shape and mature the quality systems and processes to meet various phases of development.

Responsibilities

• Establish and maintain a risk-based, fit-for-purpose Global Quality Management System (GQMS) for JEB. Develop, communicate, and ensure implementation of the Quality Manual, Quality policy, standards, global procedures and processes across the JEB.
• Responsible for establishing and maintaining globally the following elements of the GQMS:
  • Document Control and Records Management
  • Data Governance and Data Integrity
  • Nonconformance and CAPA
  • Change Control
  • Quality Risk Management
  • Data Management including Quality Management Review
• Responsible for the global electronic quality management (eQMS) for JEB.
• Interact internally and externally with quality and site management to report on the performance of the quality system.
• Establishing department / individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable department and delivery metrics
• Develop and lead the Quality Management Review process, ensuring all sites report performance and system health.
• Perform as a Subject Matter Expert in audits and inspections.
• Coaching, training, and supporting development of the Quality Systems team.
• Ensure adherence to the budget.
• Driving continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems, and instilling strong ownership and accountability.

Qualifications

• B.S. Degree in business or a scientific/technical field required. Advanced degree such as MBA or master’s desired.
• Minimum of 15 years’ experience in multinational pharma/biopharma organizations, covering Broad knowledge and experience with quality assurance and quality system, quality operations, regulatory compliance and understanding of current international regulatory requirements and trends for the manufacturing of API, DS and DP and advance therapies.
• Ability to solve organizational problems across sites to ensure standardized application of quality system practices.
• Demonstrated leadership across functions and organizational levels.
• Experience in strategy development and deployment, organizational change, and business improvement.
• Strong people leader to engage and motivate a team of professionals.
• Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of the GQMS.
• Demonstrates excellent interpersonal verbal and written communication.
• Ability to deal with complexity, ambiguity, and multiple priorities simultaneously.
• Travel to JEB local and international sites as required.

The base pay range for this position at commencement of employment is expected to be $127,050 - $235,950; 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.