Senior Manager, Commissioning Qualification Validation

·       Directly manage Equipment Commissioning & Qualification equipment qualification and computerized system validation teams.

·       Manage and allocate resources responsible for teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to existing equipment and standalone/enterprise computerized systems.

·       Define the needs, benefits, and technical strategy within the project life-cycle and overall processes.

·       Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.

·       Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.

·       Maintain departmental commissioning and qualification procedures and policies. Ensure site and project master plans comply with global policies and regulatory agency requirements.

·       Ensure resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.

·       Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.

·       Ensure compliance with Facilities Services Qualification Master Plan.

·       Oversee the site requalification activities and requalification programs.

·       Responsible for developing and managing budgets and resources for the program.

·       Create departmental metrics; understand, review, and deliver metrics to the team to determine areas for improvement.

·       Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.

·       Expert knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.

·       Ability to develop, delegate, and motivate others including direct and indirect reports.

·       Strong financial acumen.

·       Solid understanding of scheduling fundamentals, execution and cost control.

·       Advanced understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.

·       Strong multi-tasking ability in conjunction with proven managing skills; ability to effectively manage multiple projects, initiatives and activities simultaneously.

·       Strong written and verbal communication skills.

·       Excellent interpersonal skills with experience working across a broad range of teams.

·       Strong presentation development and delivery skills.

·       Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business tools.

·       Working knowledge of scheduling software and systems, and inventory management systems, mainly CMMS.

·       Ability to create and analyze meaningful metrics.

·       Experience with departmental capital and expense budget forecasting and management.

·       Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.

·       Ability to sit, stand, walk and move within workspace for extended periods.

·       Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.

·       Primarily an office environment. Will be required to enter laboratories or GMP process areas donning proper gowning/lab coats or PPE such as safety glasses and shoes.

·       Ability to work safely and effectively when working alone or working with others.