Senior Manager, Computer Systems Validation

Reporting to the Director, Information Technology, the Sr. Manager, Computer Systems Validation (CSV) will be a core member of the Information Technology team and responsible for the implementation, management, ongoing support and review of Just-Evotec’s internal GxP validated systems. This individual will ensure IT Quality and Risk Management standards are defined, understood, designed into work activity and achieved. This individual will manage day-to-day operations for CSV, working closely with key stakeholders from business teams, particularly QA, heavily guiding business teams on validation principals and requirements throughout the system lifecycle. This role will ensure compliance risks are identified, mitigated and managed appropriately.

Skills:

- Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies.

- Ensure compliance and the validated state of all GxP systems

- Generates metrics related to the CSV program.

- Support and provide guidance to cross-functional groups with GXP system implementation projects and ongoing validation needs including revalidation, periodic review of system controls, security, and segregation of duties.

- Responsible to manage external CSV consultants in CSV projects.

- Maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles and GAMP5 practices.

- Identify and track progress against key project milestones partnering with applicable business process, equipment, and facilities owners along with any external providers to ensure overall project success and compliance.

- Serve as the subject matter expert (SME) regarding Data Integrity and CSV lifecycle.

- Partner with IT Operations, Business Owners, Technical Owners and Quality on continuous improvement of data management practices and documentation relating to the application of ALCOA+ principles of GxP data integrity throughout the data lifecycle, including data mapping and criticality assessments.

- Support computer systems Risk Based Assessment and gap assessment remediation activities.

Requirements:

- Working knowledge of GxP regulations and CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.

- Knowledge of Quality Risk Management per ICH Q9 and its application to CSV.

- 5+ years of CSV experience.

- 8-10+ years in a pharmaceutical, biotechnology, medical device or related environment.

- Experience in managing CSV teams preferred.

The base pay range for this position at commencement of employment is expected to be $150,000 to $185,000; 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 and 401k company match, flexible 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.