Associate Director - Computer System Validation Lead
Scorpion Therapeutics, Indianapolis, Indiana, us, 46262
Role Summary
Associate Director - Computer System Validation Lead will provide technical leadership across site and global IT groups focusing on Computer System Validation strategies, regulatory compliance, and global policies and procedures for validating, maintaining, and retiring computer systems.
Responsibilities
Oversight of computer systems validation strategies and activities across new API facilities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate.
Define the risk management approach to be followed by new API facilities.
Define the inspection readiness approach for new API facilities.
Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements.
Support Data Integrity readiness for regulatory authority inspections and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity.
Ensure we have consistent and reusable CSV strategies and artifacts across all New API facilities.
Participate in business plan activities and in appropriate site governance and steering teams.
Create a standard approach for GMP designation and testing requirements for site systems.
Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements.
Must ensure security and privacy risks are considered in the design and testing of IT systems.
Qualifications
Required: Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
Required: 10+ years experience working in a Pharma industry (i.e. GMP) and strong understanding of quality processes in IT applying to Pharma manufacturing and distribution.
Required: Experience in CSV Strategy Development and Execution
Required: Experience in supporting regulatory audits; both readiness and audit support.
Required: Hands on experience in execution Manufacturing and/or Lab systems CSV testing in the shop floor.
Preferred: Experience in Lab systems and instrument CSV
Preferred: Leadership skills – proven leadership experience in managing cross-functional teams.
Preferred: Industry engagement – active participation in industry forums and standards organizations.
Preferred: Strong experience managing multiple concurrent initiatives and projects with aggressive timelines.
Preferred: Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to management and peers across multiple business functions.
Preferred: Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Preferred: Strong collaboration with colleagues at all levels.
Preferred: Demonstrated courage & integrity.
Preferred: Demonstrated success in influencing without authority.
Preferred: Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Preferred: Highly flexible, adapting to changes in priorities, requirements and processes.
Preferred: Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
Preferred: Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems.
Preferred: Recognized understanding of regulations governing CSV and data integrity.
Education
Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
Skills
Leadership and cross-functional collaboration
Regulatory and data integrity awareness
Technical documentation and presentation skills
Strong communication in English (written and verbal)
Knowledge of CSV, GMP, and cyber/privacy considerations in IT systems
Additional Requirements
Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off-hour work may be required.
Position will be based out of Indianapolis Indiana.
Up to 15% of Business Travel time. Due to the different locations of the New Facilities, extended duration business travel may be required base on business needs.
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Responsibilities
Oversight of computer systems validation strategies and activities across new API facilities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate.
Define the risk management approach to be followed by new API facilities.
Define the inspection readiness approach for new API facilities.
Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements.
Support Data Integrity readiness for regulatory authority inspections and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity.
Ensure we have consistent and reusable CSV strategies and artifacts across all New API facilities.
Participate in business plan activities and in appropriate site governance and steering teams.
Create a standard approach for GMP designation and testing requirements for site systems.
Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements.
Must ensure security and privacy risks are considered in the design and testing of IT systems.
Qualifications
Required: Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
Required: 10+ years experience working in a Pharma industry (i.e. GMP) and strong understanding of quality processes in IT applying to Pharma manufacturing and distribution.
Required: Experience in CSV Strategy Development and Execution
Required: Experience in supporting regulatory audits; both readiness and audit support.
Required: Hands on experience in execution Manufacturing and/or Lab systems CSV testing in the shop floor.
Preferred: Experience in Lab systems and instrument CSV
Preferred: Leadership skills – proven leadership experience in managing cross-functional teams.
Preferred: Industry engagement – active participation in industry forums and standards organizations.
Preferred: Strong experience managing multiple concurrent initiatives and projects with aggressive timelines.
Preferred: Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to management and peers across multiple business functions.
Preferred: Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
Preferred: Strong collaboration with colleagues at all levels.
Preferred: Demonstrated courage & integrity.
Preferred: Demonstrated success in influencing without authority.
Preferred: Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Preferred: Highly flexible, adapting to changes in priorities, requirements and processes.
Preferred: Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
Preferred: Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems.
Preferred: Recognized understanding of regulations governing CSV and data integrity.
Education
Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
Skills
Leadership and cross-functional collaboration
Regulatory and data integrity awareness
Technical documentation and presentation skills
Strong communication in English (written and verbal)
Knowledge of CSV, GMP, and cyber/privacy considerations in IT systems
Additional Requirements
Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off-hour work may be required.
Position will be based out of Indianapolis Indiana.
Up to 15% of Business Travel time. Due to the different locations of the New Facilities, extended duration business travel may be required base on business needs.
#J-18808-Ljbffr