Senior Manager, Process Transfer, Development & Validation

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions is seeking a Senior Manager, Process Transfer, Development, and Validation. This individual is responsible for managing the process transfer, development and validation program to support Grifols Immunodiagnostic NAT and BTS products.  This role includes defining and prioritizing process transfer, development and validation activities and managing resources to meet organizational objectives, ensuring that the transfer and validation program complies with all Grifols requirements and industry standards, and partnering with Manufacturing, MTS and Engineering.  The individual is also responsible for setting department objectives, expectations for the staff, and developing individual and team performance.

 

Responsibilities

• Direct the process transfer, development and validation activities to support GMP manufacturing in accordance with appropriate regulatory requirements, cGMPs, corporate policies and procedures.
• Establish strategic goals and objectives, including prioritization, coordination, and completion, of GMP process transfer, development and validation projects.
• Evaluate existing processes and validation packages to ensure they meet the current FDA guidance and Grifols guidelines.
• Participate as subject matter expert in cross functional meetings related to process transfer, development and validation.
• Ensure the program adequately defines transfer, validation, revalidation and/or requalification requirements and activities are performed within the establish intervals.
• Ensure appropriate acceptance criteria are applied and justified for all process transfer, development and validations.
• Work closely with cross-functional partners such as R&D, MTS, Manufacturing, QC, and QA.
• Describe and defend process transfer, development and validation program during audits and inspections.
• Provide leadership for the group and work with validation staff to assist in the ensure success of on the job training of personnel as well as evaluate the effectiveness of training.      
• Manage and develop staff by setting individual and group goals and manage performance based on Grifols guidelines
• May require travel up to 10% to vendors or other Grifols sites.
• Manages process transfer, development and validation activities to ensure processes remain compliant with cGMP and regulatory requirements through monitoring, trending, CPV program and auditing.
• Responsible for driving and validating process improvements in manufacturing
• Manages and sets department budgets as necessary                              

 

Knowledge, Skills, and Abilities

• Excellent interpersonal effectiveness and communication skills (written and oral) required to work across departments and management levels.
• In-depth knowledge of commercial manufacturing, tech transfers and validation requirements
• Expertise with cGMP
• Creative, organized, self-motivated, perceptive and innovative
• Ability to manage diverse groups of technical and leadership staff to leverage their diverse strengths and skills
• Possesses individual and team performance management skills
• Demonstrates flexibility to manage multiple priorities and delegate appropriately
• Demonstrates direct expertise with Lean, 5S, Operational Excellence
• Demonstrates excellent skills in leading discussions of data with peers such as scientists and functional area managers    

 

Education

BS and MS in Mechanical or Chemical Engineering, Science, or related field.

 

Experience

• 10-15 years’ experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations, cGMPs, FDA regulatory guidelines and validation principles.
• 8-10 years of experience managing with strong leaders