Job Description:
- Responsible for oversight, maintenance, and management of the Baltimore Site Validation Program.
- Prepares, revises and/or executes Validation master plans, commissioning documents, Validation protocols, Validation summary reports and annual reviews for equipment, systems, and processes.
- Stays current on worldwide requirements and identifies gaps and implements program changes and improvements to remain in global compliance.
- Interacts with the required departments to ensure Validation activities are completed on time and in a quality manner to ensure compliance with applicable regulatory standards and guidelines.
- Develops, recommends and makes recommendations regarding associated Validation strategies, execution sequences and test plans.
- Trains, and directs staff of operating department(s) who are performing the execution of studies in their area(s). Successful execution of this role results in continuous ongoing global regulatory compliance of all facets of the Validation program and operation, which contributes to the uninterrupted supply of product to patients.
Essential Functions and Responsibilities
- Manages and is responsible for the overall established Validation program to ensure worldwide regulatory compliance at all times.
- Writes and is accountable for the execution of Validation/Revalidation protocols, reports, master plan, SOPs, FATs, Annual Validation Reviews, etc…for equipment, systems, and processes in a timely and quality manner according to requirements, as well as industry and global regulatory standards/guidelines. Oversees Validation consultants/activities for the new manufacturing site.
- Trains and oversees other site personnel in Validation protocol/SOP execution. Manages outside contractors as needed. Resolves protocol and execution discrepancies to a satisfactory conclusion including determination of associated root cause(s) and planning, appropriate follow up actions and systemic changes, as required
- Interacts with applicable departments and outside vendors before, during, and after Validation activities to gather required information, ensure teams are well informed, and maintain manufacturing and company guidelines as well as global regulatory compliance.
Attend onsite and offsite meetings as required to represent Validation and make recommendations and/or decisions regarding test strategies, approaches, and timing. Validation subject matter expert for all audits and inspections.
Scope Measures
- No direct cost center ownership, but works closely with manager/cost center owner(s) on activities with financial implications.
- Responsible for Validation planning/scheduling activities and timelines which have impact on manufacturing and global product supply
- Ensure that the defined number of routine Revalidations as stated in the Validation master plan are all completed on time.
- Accountable for the site Validation program and is the area subject matter expert.
- Oversees Validation consultants/activities for the new manufacturing site
Knowledge/Skills/Abilities Required
- B.S. degree in engineering, biology, pharmaceutics, or related science discipline
- 8-12 years of related experience within pharmaceutical industry
- Minimum of 8 years of Validation experience in the pharmaceutical industry including writing, executing, and summarizing Validation protocols and SOPs for equipment (autoclaves, ovens, temperature controlled units, etc) systems, and processes
- Minimum of 5 years Validation Management experience (in the pharmaceutical industry).
- Experience with cleaning Validation and setting acceptance limits
- Thorough knowledge of FDA, ICH, EU, PMDA and other global regulations and GMP guidelines associated with Validation requirements
- Experience with/participation in FDA and other worldwide agency inspections.
- Validation SME in this area.
- Experience with Kaye data logger equipment
- Proven ability to manage projects and meet established milestones and overall objectives in a timely, accurate and efficient manner.
- Ability to consistently role model the Values of Integrity, Respect Professionalism, Quality, Teamwork
Also must possess:
- Strong verbal, organization, writing, and troubleshooting skills
- Ability to read, understand, interpret, and apply technical writing and instructions
- Experience with regulatory inspections
- Demonstrated results and effectiveness as contributing team member and/or leader of a multi-functional team or effort.
- Demonstrated success in leading teams/projects
- Ability to work across organizational boundaries and with various levels
- Motivation and the ability to work with minimal direction and oversight
