Regional Vice President for Ambulatory Surgery Centers overseeing operations, financial management, and strategic partnerships. Leading growth initiatives and enhancing healthcare delivery in New Jersey.
About the role
- Associate Director of Automation at Global Clinical Supply developing automation strategies and ensuring compliance in pharmaceutical operations and technologies. Leading project execution and team training.
Responsibilities
- Lead startup of systems-related aspects of new operational facilities and equipment
- Lead system-related aspects of new technology deployment such as system development lifecycle (SDLC), assessments of data integrity, privacy, risk, and other aspects necessary for GxP use
- Implement automation solutions, including both platform technologies and associated analytics, reporting, and visualization capabilities
- Develop and complete appropriate system validation, Change Control and testing documentation, ensuring compliance with all requirements.
- Support of systems upgrades/maintenance, and new software/systems install
- Reviewing automation documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with Good Manufacturing Practice and safety.
- Partner with business areas to develop processes to enable use of technology & equipment
- Developing and supporting corrective actions for investigations related to automation or IT systems.
- Conduct or support automation system-related investigations and implement necessary CAPAs.
Requirements
- At least 7 years of experience in an information technology and/or operations role within the pharmaceutical industry
- Experience with pharmaceutical facility and equipment commissioning, qualification, and validation (CQV)
- Development and execution of equipment and facility automation-related CQV strategies.
- Strong compliance mindset and understanding of cGMP, including FDA and EMEA
- Works effectively across boundaries to build strong collaborative relations with other groups
- Direct support of validation activities and compliance-related requirements functions.
- Willing to constructively challenge the status quo and explore continuous improvement opportunities
- Strong abilities in Stakeholder Management and building and strengthening cross-functional networks
- Excellent communication skills
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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