Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Job Title: IT Compliance and Risk Management Associate Director MQO IA/IS
Job Responsibilities/Department description:This position will establish and provide IT Compliance, risk management, security, auditing, change management, computer system validation support within the MQO- IAIS organization and site IAIS teams. This role will be responsible for implementing quality/compliance systems or programs within IAIS, establishing processes and procedures utilizing industry best practices to ensure compliance with quality standards and regulations. This position will facilitate and ensure compliance objectives are met through establishing and managing investigations, compliance commitments, training, audits, conducting periodic reviews of system security access and documentation to ensure compliance to departmental procedures and quality standards. The role will interact closely with IAIS, Quality and other areas of the business and may also involve management/supervision of additional compliance resources and/or contractors.
As a member of MQO IA/IS (Manufacturing, Quality and Operations, Industrial Affairs IS) this position encompasses:-Strong cGMP Compliance/Regulatory experience. Knowledge and experience in IT, risk management, computer systems validation, deviation/investigations, CAPAs, auditing, and training a plus.
-Management/supervision of compliance resources or contractors responsible for providing compliance expertise and service to the MQO-industrial Affairs Information Services organization.
- Conduct risk assessments and implement quality & risk management tools and techniques based on industry best practices.
- Develop, manage and maintain departmental programs, procedures, and documentation in alignment with quality and corporate standards.
- Review/approve computer system validation deliverables and provide compliance support to validation projects within IAIS
- Generate, track and report on compliance to quality systems metrics such as deviations, commitments, periodic reviews and training. Communicate compliance status to management.
- Facilitate and support IAIS personnel in navigating quality systems tools, methodologies, and procedures to ensure compliance and issue resolution.
- Determine the training requirements for IS personnel, establish and maintain curricula based on job role, develop training materials as needed.
- Review and approve departmental documentation including procedures, validation documentation and change controls.
- Oversee and support periodic review of security access, system compliance, system inventory, and documentation as needed.
- Responsible for participating and/or supporting sites in audit and inspection activities. Provides input into audit responses.
- Establish vendor audit program and perform internal audit readiness activities and exercises to ensure compliance within IAIS. - Ability to function with little appreciable day to day direction.
- Strong written and verbal communication skills.
- Change management and/or project management experience.
- Bachelors Degree
- A minimum of 10 years experience working in a regulated / GMP environment. Pharmaceutical and/or biopharmaceutical required with software development lifecycle, validation, enterprise systems, manufacturing / automation systems.
- Writing documentation including but not limited to specifications, protocols, summary reports, and standard operating procedures. Prior management/supervisory experience.
- Masters degree
- Interpersonal and negotiation skills, ability to work naturally/well in a team environment and influence and foster collaborative relationships
Excellent verbal and written communication skills
Excellent organizational skills
Experience with IT regulatory areas a plus (SOX)
Experience with lean, continuous improvement methodologies a plus
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