Job Title: Sr. Quality Director, IT System Compliance
Location: Center Valley, PA
Number of direct reports: none
The Senior Quality Director, IT System Compliance is responsible for ensuring system compliance with applicable regulations throughout the software life cycle of development, implementation and maintenance of automated systems that support cGMP processes including Quality oversight and alignment with the Division’s global quality system. The role is accountable for partnering with IT and Quality to ensure the establishment of adequate validation, electronic infrastructure and defensible data integrity, including IT SOX compliance and Computer Information Security.
- Oversees all aspects of the company's Computer System Validation and global IT activities for the systems that support cGMP processes for this division
- Partner with Operations, IT, Finance and other QA personnel in the development, implementation, project management, release, periodic review and maintenance of new and/or updated IT systems.
- Ensure the integration of Risk Management tools as part of a compliant Computer System and Automation Validation approach.
- Plan, organize, and direct the functions of QA Automation Validation and IT SOX compliance.
- Create clear vision, propose plan(s) and manage project deliverables to prepare the organization to support the growing Computer System and Automation validation needs of the business, including enhancement and optimization of Computer System Validation program.
- Establish effective communication and collaborative relationships with all Clinical Trials Division business units, global sites and key stakeholders.
- Develop/revise and implement QA IT and Computer System Validation policies and procedures to ensure global harmonization and alignment between global operating sites.
- Provide subject matter expertise during regulatory and customer inspections of Clinical Trials Division business sites.
- Proactively establish, communicate and lead the QA and Validation strategies, needs/requirements and associated plans of existing and new computer systems.
- Support and work with the Clinical Trials Division site QA organizations to ensure that the validation of computer systems is maintained during the system life cycle.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the Clinical Trials Division.
- Proactively identify, communicate upward and diligently project manage the resolution of any critical, high-risk compliance deficiencies with effective resolution management through the current quality system for deviations, risk management and change control.
- All other related duties as assigned by the Vice President of Quality and Regulatory
- 15+ years’ experience in a cGMP-regulated environment, with exhibited knowledge and proficiency of system validation and quality activities.
- 10+ years experience overseeing Validation / Quality Assurance activities.
- Bachelors degree in science or engineering. Advanced Degree is desirable.
- Demonstrated leadership, technical, communication, management, problem solving, risk management and project management skills.
- Organizational and management skills to handle multiple global functional groups, with ability to effectively delegate work within a matrix environment.
- Demonstrated ability to organize and enhance the maturity level of the IT and IT / QA functions through strategic plans and mentoring of IT and QA staff.
- Ability to speak, present data and defend approaches in front of an audience and/or inspectors.
- Experience in participating in regulatory inspections, presenting/defending divisional functions in audits or regulatory inspections.
- Ability to comprehend technical information related to computer system development, life cycle maintenance, computer validation, regulatory or SOX requirements.
- Working understanding and familiarity with FDA, European and Asia Pacific regulatory requirements, guidelines and recommendations for computer systems.
- Robust problem-solving skills and attention to detail.
- Multi-cultural exposure and understanding; global thinker.
- Superior leadership skills including experience managing within a matrix environment.
- Ability to collaborate at all levels across the organization.
- Demonstrated ability to formulate strategy and drive to tactical execution with verifiable results.
- Ability to travel as business requires (15-20%).
- Detailed knowledge of Computer System Validation, IT Quality Assurance, Software Development Life Cycle requirements and Regulatory Affairs compliance.
- Experience leading global IT Quality and Computer System Validation initiatives.
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