This position leads the establishment and maintenance of the company's quality systems and processes in order to adhere to cGMP requirements world-wide. This person works with top management to establish company policy and standards on product quality through an efficient, effective and compliant, well documented cGMP system. This role as has responsibility for the technical leadership and accountability for computer system validation and ensures compliance with internal and external computerized system policies and regulations. This individual will ensure sites are fundamentally aware of and proactively implement current computerized system validation practices with particular focus on impact to patient safety, product quality and record integrity. The position scope includes local and global site systems.
Location: Bridgewater NJ
Responsible for the establishment and maintenance of Global Quality Manual.
Responsible for the establishment and maintenance of Global Directives and procedures which define the requirements of the Global Quality System.
Assures change control activities are appropriately planned and executed to ensure compliance to all regulations and standards.
Assures critical to quality documents are appropriately filed and maintained for continuous retrieval and change.
Lead computer system validation for local and global sites including automated lab equipment software, data tracking and trending software, quality systems software and associated business system interfaces.
Determine computer system validation strategy for system qualification in alignment with company systems and collaborate/lead in decision-making and make recommendations regarding best options.
Communicate proactively with stakeholders and management regarding progress, issues and plans for resolution and to ensure the project team and/or network is fully informed of updates and improvements.
Develop computer system validation related content; controlled documents to support the start-up, validation, operation and maintenance of site GMP computerized systems, for project qualification plans and protocols.
Ensure the site(s) are compliant with current corporate global computerized validation policies and legislative requirements by setting and maintaining computerized system validation standards via computerized system validation SOPs.
Ensure all centrally produced tools, templates and materials are available and relevant to site.
Support Regulatory inspections and internal and partner audits, and implement corrective actions as needed. Provide Computer System Validation related responses to inspectors/auditors.
Measure and report project execution progress.
Ensure that the computer system validation efforts are directed at the systems that have the potential to impact product quality, efficacy and data integrity using a variety of tools including GAMP 5.
Scope of Position:
Direct reports at the region/global level with an overall department. Lead a network of business process, documentation, quality systems and software quality professionals across the organization and leverage resources in an efficient, effective manner.
Operations leadership at the manufacturing plant and executive levels, functional leadership (e.g. IT, Regulatory Affairs, Clinical, Medical Affairs, Legal, R&D, etc.), Regional Quality and Operations senior leaders, Global Quality Leadership staff members
BS degree in a technical or scientific discipline including Engineering or Computer Science. Minimum of five (5) years in the pharmaceutical industry with GMP experience and expertise as a practicing professional in the area of computer system validation. Ten (10) years preferable.
Areas of expertise include validation of cGMP computerized systems within an FDA regulated environment.
Comprehensive knowledge of Validation lifecycles for site and global systems (i.e., IT, Analytical Equipment, Spreadsheets, Oracle, CatsWeb, D2)
Practical experience with quality risk management and risk based validation approaches.
Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500.
Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, Part 820 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects.
Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project.