Poistion will be based Remotely

In this key role, you will be part of a technical professional team involved in the corporate Global Technical Operations (GTO). GTO is dedicated to the oversight of the development and commercialization of quality drug products. You will be viewed as a subject matter expert on requirements, methodology, industry standards, and best practices of Validation within the Pharmaceutical Industry. Your ability to use a team approach for managing initiatives in quality, validation, and compliance is a critical success factor. You will interface with site and corporate Engineering, Manufacturing, Technical Operations, Quality, Product Development, PPI, Validation, and other departments as needed in the accomplishment of his/or her objectives.

Primary Responsibilities

• Manage and support multi-site diagnostic activity to identify gaps in validation processes, practices, systems, and talent. Drive actions and provide expertise to develop solutions across the network that address gaps.
• Work closely with Validation, Quality, Engineering, Technical Operations, and other functions to define and implement standards, guidelines, and best practices for Validation. This includes Process Validation, Cleaning Validation, Commissioning and Qualification (C&Q), and others.
• Drive improvement/standardization in key Validation areas including Strategy, Quality Risk Management (QRM), Master Planning / Revalidation, Analysis/Testing approaches, and others.
• Partner with the Continued Process Verification (CPV) Business Process Owner (BPO) and other leaders to ensure a streamlined, well aligned approach across the 3 Stages of Life-Cycle Validation.
• Manage initiatives to develop and implement operating systems, process flows, and management tools for effectiveness throughout the Validation function.
• Work with Corporate Quality, Technical staff, and Audits to develop and manage sustainability assessments and compliance audits to ensure effective Validation and to drive improvement.
• Partner with PPI and other functions to drive continuous improvement
• Demonstrate highly effective oral and written communication skills and strong leadership ability. Be able to engage leadership and teams at different levels in the organization.

Education

• Bachelors or Masters in chemical/mechanical/pharma engineering/science or related field
• MS and 5+ yrs. of relevant work experience, Bachelors and 10+ years of relevant work experience

Experience

• 8 yrs. of proven leadership ability including managing teams, people, and technical projects
• Proficient knowledge of FDA regulatory requirements, quality systems, data integrity requirements, and cGMP for validation and pharmaceutical operations.
• In Depth of knowledge and proven performance in validation for pharmaceutical operations.
• Knowledge of C&Q, ISPE Baseline Guide, GAMP, and industry best practices is preferred.
• Strong written and oral communication skills. Able to write detailed technical reports.
• Ability to work cross-functionally and at multiple levels of the organization.
• Knowledge of pharmaceutical business processes and equipment.
• Professional CQE or Lean Six Sigma certification not required but preferred.
• Ability to travel a minimum of 50% on an annual basis.

The position has not been approved to provide relocation assistance.