Just-Evotec Biologics, a wholly owned subsidiary of Evotec SE, is a pioneering biologics platform company dedicated to revolutionizing the development and manufacturing of biotherapeutics. Leveraging advanced AI/ML technologies and world-class expertise in molecular design, cell line development, and continuous manufacturing, we accelerate the journey from discovery to commercial launch. Our mission is to expand global access to affordable and high-quality biotherapeutics, breaking through scientific and economic barriers. Based in Seattle, Washington, our team combines deep industry experience with innovative solutions to drive transformative progress in the biologics landscape.

Responsibilities

Team Management:

• Supervise a team of 10 (7 FTEs and 3 contractors).
• Manage group FTE and contractor assignments.

Vendor and Account Management:

• Oversee internet connections and vendor management (Comcast, Ziply).
• Manage GoDaddy account for domain registration, delegating access as needed.

Telephony and Software Licensing:

• Manage telephony systems (Goto Connect, Comcast) and consolidate services.
• Handle software licensing needs, liaising with scientists and IT for renewals.

Administrative and Operational Duties:

• Administer Smartsheet and manage SO roles for GxP software titles.
• Negotiate SO roles for DeltaV with the automation team.
• Oversee daily ticket management and serve as the main POC for incidents at Red Sea and TLS.
• Act as the main POC for legal queries and audit preparations.

Procurement and Project Support:

• Manage procurement processes for Red Sea IT (Coupa and credit card).
• Provide contractor management (PO approval) and project support for TLS.

Meetings and Collaboration:

• Participate in twice-weekly GWS leadership meetings.
• Attend recurring meetings and manage Teams groups for various collaborations.

Requirements

GxP (Good Practice) Compliance

• GxP Software Titles: Ensuring that all software used in regulated processes complies with GxP standards. This includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) among others
• Documentation: Maintaining thorough documentation for all IT systems, including development, configuration, testing, maintenance, and decommissioning. This documentation is crucial for demonstrating compliance during audits.
• Training: Ensuring that all team members are trained on GxP requirements and understand the importance of compliance in their daily tasks

Validation

• Validation in IT management ensures that systems and software meet their intended purpose and comply with regulatory requirements. Key aspects include:

• System Validation: Conducting thorough validation of all IT systems to ensure they meet specified requirements and perform as expected. This includes both initial validation and ongoing re-validation as systems are updated or modified.
• Risk Assessment: Performing risk assessments to identify potential impacts on patient safety, data integrity, or product quality. This helps in prioritizing validation efforts and ensuring critical systems are robust and reliable.
• Testing and Verification: Implementing rigorous testing protocols to verify that systems function correctly and consistently. This includes unit testing, integration testing, and user acceptance testing.

FDA Audit Readiness

• Being prepared for FDA audits involves maintaining a state of constant readiness and ensuring that all processes and documentation are in compliance with FDA regulations. Key elements include:

• Documentation Management: Keeping comprehensive and well-organized documentation that clearly demonstrates compliance with FDA regulations. This includes batch records, deviation reports, and corrective and preventive actions (CAPAs).
• Training and Awareness: Ensuring that all team members are aware of FDA requirements and are prepared to articulate their roles and responsibilities during an audit. Regular training sessions and mock audits can help in maintaining readiness.
• Continuous Improvement: Implementing a culture of continuous improvement where issues are promptly addressed, and processes are regularly reviewed and updated to ensure ongoing compliance. By focusing on these areas, the IT End User Services Manager will play a crucial role in maintaining compliance and ensuring the organization is always prepared for regulatory audits.
• Excellent problem-solving skills and the ability to work independently and as part of a team.

Soft Skills

• Strong Communication: Ability to clearly convey technical concepts to non-technical stakeholders.
• Team Collaboration: Proven ability to work effectively in a team environment and collaborate with cross-functional teams.
• Problem-Solving: Strong analytical skills to troubleshoot and resolve complex issues.
• Adaptability: Ability to quickly adapt to new technologies and changing business requirements.
• Time Management: Excellent organizational skills to manage multiple tasks and projects simultaneously.
• Attention to Detail: Meticulous attention to detail to ensure high-quality deliverables.
• Customer Focus: Commitment to providing excellent service and support to internal and external customers.
• Proactive Attitude: Initiative to identify opportunities for improvement and drive positive change.

Work Hours and Flexibility

• Standard work hours are 9 AM - 5 PM, Monday to Friday.
• Flexible working hours and remote work options are available to accommodate work-life balance.
• Occasional on-call duties may be required to address urgent issues outside of regular hours.

Preferred Qualifications

• Proven experience in IT management, particularly in end-user services.
• Strong vendor management and negotiation skills.
• Proficiency in telephony systems and software licensing.
• Excellent team management and leadership abilities.
• Effective communication and collaboration skills.

Preferred Skills

• Knowledge of GxP software titles and DeltaV systems.
• Experience with Smartsheet administration.
• Familiarity with audit preparation and legal query management.

The base pay range for this position at commencement of employment is expected to be $145,000 to $175,000;  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.