Seeking a highly motivated individual to join our information technology group to lead all Quality and Product Sciences/Development systems such as LIMS, ELN, QMS, LMS and Document Management system. This will be a critical role within our information systems group reporting to the Senior Director of Enterprise and Technical Operations systems. It is a highly cross functional role working closely with the senior leadership team from various business groups dealing with GxP Systems.
KEY RESPONSIBILITIES (include but are not limited to):
Operational ownership of various Quality and Product Sciences/Development systems in an FDA regulated biotech or pharmaceutical environment.
Bring best practices to deliver solutions for the business problems through experience driven vision, planning and hands on experience with in a regulated GxP environment.
Work closely with Quality and Production Sciences business leadership team to understand their technology requirements and identify/implement “best fit” technology solutions to meet their needs.
As a system owner, responsible for the prioritization and execution of new systems or enhancements to existing systems and supporting day to day operations of various Quality and Product sciences systems like LIMS, QMS, LMS Quality Document Management System etc.
Enforce IT Governance and Change control amongst IT and business teams to prioritize and implement improvements for all Quality systems.
Collaborate closely with other IT groups (infrastructure, service desk, IT security, and portfolio management) on the overall IT solutions delivery process and infrastructure and database requirements.
Assist in evaluating vendor solutions, develop alternatives and recommend technical solutions in meeting the evolving needs of the quality and production development group.
Lead and manage quality system implementations from requirement management through testing and validation.
Collaborate with Quality team on computerized system validation activities like IQ/OQ/PQ and other regulatory and internal SOX Audit to ensure the compliant and validated state of all Quality and Product Development systems.
Own change management and governance process for Quality and Product Sciences systems.
Own system administration and integration of quality systems with other enterprise and technical operations systems.
Assist in developing SOPs, Work instructions and other relevant documentation for quality systems administration.
Own internal and external teams to implement and manage quality systems and release management
Manage vendor relationship to identify and implement quality and other GMP systems.
Lead the implementation of the integrations between LIMS and other quality and manufacturing systems with lab instruments and other GMP and corporate systems like Oracle EBS, MES etc.
Identify and lead the implementation of analytics solutions for quality and product sciences groups to deliver KPIs related to Quality data and process monitoring.
REQUIRED SKILLS AND KNOWLEDGE:
BS or MS in a Life Sciences, Engineering, Computer science or related field.
Minimum of 15 years of working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT).
Knowledge of CGMP/ICH/FDA regulations with 21 CFR Part11. GAMP knowledge will be a plus.
Minimum of 5 years of experience in implementing systems for Quality and Product sciences and integrating them with other enterprise and technical operations systems.
Experience with various lab instruments used with product development and manufacturing and integrating them with other systems.
Experience in implementing and supporting systems quality systems like LIMS, QMS, LMS, Document Management Systems. Any experience with Labvantage LIMS, Oracle Agile QMS, ComplianceWire, and Veeva Quality Document system will be a plus.
Experience with Manufacturing Execution system, Electronic Batch Records systems like Werum and integrating it with LIMS and other quality systems will be a plus.
Experience in building a data warehouse for biotech or pharmaceutical organization, with data from various quality, product development and manufacturing systems.
Experience in identifying and implementing the data visualization tools to present the data for process monitoring and other reporting in a pharmaceutical environment.
Experience in handling infrastructure and instruments qualifications and validations for regulatory requirements.
Experience with emerging cloud, SaaS and web technologies.
Ability to handle conflicting priorities from various business groups and prioritize them based on the business requirements and resource availability.
Experience in implementing and leading change management and governance process, owning deviations and change control in a regulated environment.
Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines in a fast paced environment.
Strong written and verbal communication and presentation skills with good executive presence to interact with senior leadership team from various business groups. Proficient in tools like Power Point, Visio and other tools to develop process flows and presentations.
Experience in leading, managing and mentoring a team of quality systems professionals.