Senior Manager Quality - Computer Systems - Remote, West Coast, USA

Just-Evotec Biologics is seeking a highly motivated Senior Manager of Computer Systems Quality and Data Integrity to join our Quality team reporting to the Senior Director of Quality Engineering and Validation. This role offers a significant opportunity to improve worldwide access to biotherapeutics by ensuring the integrity, compliance, and validation of critical computerized systems supporting our biologics manufacturing operations.

The Senior Manager of Computer Systems Quality and Data Integrity will establish and maintain comprehensive validation and data integrity programs for all GxP computerized systems within our manufacturing network. This position is responsible for developing and implementing policies, procedures, and strategies that ensure compliance with applicable regulations including 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. The ideal candidate will provide leadership in computerized systems validation, data governance, and electronic records management while collaborating across multiple departments to support GMP operations.

Key Responsibilities

• Establish and lead data integrity and governance initiatives across the organization.

• Develop risk-based approaches to protect data integrity in both electronic and paper-based systems.

• Create governance frameworks, implement appropriate technical and procedural controls.

• Establish data lifecycle management processes from generation through retention and disposal.

• Develop comprehensive validation strategies and master plans for computerized systems throughout their lifecycle.

• Ensure consistent application of validation approaches across the J.POD Manufacturing network.

• Lead the development of streamlined, risk-based validation methodologies that balance compliance with operational efficiency.

• Develop and maintain quality system elements specific to computerized systems including SOPs, work instructions, and validation documentation.

• Develop and deliver training programs on data integrity principles, computerized system validation, and regulatory expectations.

• Ensure personnel understand their roles in maintaining data integrity and system compliance.

• Mentor junior staff and provide technical guidance to quality team members on validation approaches.

• Keep validation teams updated on industry best practices through ongoing education opportunities.

• Develop role-based training matrices for personnel involved with computerized systems.

Qualifications, Education and Experience

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field; advanced degree preferred.

• Minimum of 8 years plus of experience in computerized systems validation and data integrity within pharmaceutical or biotechnology industry.

• At least 5 years in a managerial role overseeing computerized systems validation programs.

• Track record of successful implementation of validation programs and data integrity initiatives.

Technical Knowledge

• Deep understanding of GxP regulations related to computerized systems and data integrity, including 21 CFR Part 11, EU Annex 11, and GAMP 5.

• Strong knowledge of validation methodologies for various types of computerized systems (LIMS, MES, EDMS, etc.)

• Familiarity with data governance principles and practices within regulated environments.

• Understanding of software development lifecycle and IT service management practices.

• Knowledge of industry guidelines from ISPE, PDA, and other relevant organizations.

Skills and Competencies

• Excellent project management abilities with experience managing multiple validation projects simultaneously.

• Strong analytical and problem-solving skills for addressing complex validation challenges.

• Outstanding written and verbal communication abilities for effectively conveying technical concepts.

• Leadership capabilities for managing validation teams and influencing cross-functional stakeholders.

• High level of attention to detail and organizational skills to ensure accuracy in validation documentation.

• Ability to interpret and apply regulatory requirements in practical, risk-based approaches.

• Strong interpersonal skills and ability to build collaborative relationships across departments.