Senior Manager, IS Quality

Position Summary:

Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager, IS Quality to build and lead our IS Quality function. The ideal candidate will be responsible for ensuring compliance with regulatory requirements, industry best practices and internal standards as well as managing quality assurance processes and leading continuous improvement initiatives within our IS department. This role involves a strategic partnership with the Quality Assurance department and cooperation with various stakeholders to enhance quality and compliance across the organization.

Job Responsibilities:

• Leadership & Management: Create and lead the IS Quality function, providing strategic direction and ensuring alignment with organizational goals.
• Quality and Compliance Oversight: Lead and/or participate in the operational execution of Quality and Compliance GxP processes including audits, regulatory intelligence, regulatory inspections, change management, and quality risk management and support strategic changes to the Quality Management System (QMS) to ensure compliance with GxP regulations and industry best practices.
• System Validation Oversight: Oversee all aspects of computerized system validation, including updates, migrations, and the planning, execution, and documentation of CSV/CSA and GxP validations, ensuring seamless integration across platforms.
• Risk Management: Implement and manage a risk-based approach to identify, assess, and mitigate compliance risks, while overseeing change control processes for IS systems.
• IS Governance: Develop and implement IS governance policies and procedures to ensure effective IS management and compliance.
• Change Management: Establish and manage change control processes for IS systems to ensure all changes are assessed, approved, and implemented in a controlled manner.
• Continuous Improvement: Drive continuous improvement through metrics, reviews, audits, and foster a culture of IS QA awareness and operational excellence.
• IS Service Management: Implement ITIL principles to manage IT services effectively, ensuring high levels of service delivery and customer satisfaction.
• Vendor & Infrastructure Management: Support the qualification of new vendors and oversee infrastructure projects to ensure robust and secure IT environments.
• Regulatory Compliance: Ensure IT systems comply with 21 CFR Part 11, GAMP 5, and other standards, while maintaining policies for GCP/GLP/GPV/CSV QA functions.
• Audit & Inspection Readiness: Oversee and or participate in internal audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. Participate in regulatory inspections and/or customer audits.
• Document & Training Management: Provide direction and support for QMS procedural document management, learning management systems (LMS), training program development, and management as they pertain to the IS Quality program.
• Project Management: Establish and/or maintain IS PMO framework and corresponding policies, procedures and tools.
• Innovation & Standardization: Standardize practices by developing SOPs and validation frameworks, while fostering a culture of innovation and forward-thinking solutions.

Required Skills:

• Proven success leading cross-functional teams in an FDA regulated environment, excellent communication and interpersonal abilities, and proficiency in quality assurance processes and tools.
• Strong technical writing skills with experience developing quality policies and procedures.
• The ability to operate independently, with limited direction to achieve organizational goals while building consensus with stakeholders and keeping leadership informed.
• Technical Proficiency: Deep expertise in the implementation and validation of IT systems using best quality practices in compliance with FDA regulations, including cloud technologies and IT infrastructure.
• In-depth knowledge of regulatory requirements and industry best practices for IS Quality, IS Governance and IS Service Management.

Education and Experience Requirements:

• Bachelor's or Master's degree in a relevant field (e.g., Information Technology, Computer Science, Engineering, Life Sciences or related).
• Minimum of 7 years of experience in IS quality assurance within the pharmaceutical, biotechnology or medical device industry, with at least 3 years in a leadership role.
• Knowledge of the typical business systems used in the life sciences industry such as ERP (SAP S/4 Hana), LIMS (Labvantage) QMS/DMS (Veeva Vaults), MES (SAP Digital Manufacturing), etc.
• The following certifications are also desirable but not required: ASQ CMQ/OE (Certified Manager of Quality/Organizational Excellence). CISA and ITIL.

The final salary offered for this position may consider many factors including location, skills education, and experience.

This is not a comprehensive list, so other expectations may arise as need be.

EOE Disability/Veterans