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 leadership, organizational planning, project management skills, in addition to strong technical background required to coordinate multidisciplinary teams. + SAP experience preferred **Equivalency** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. **Occupational Demands** Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. **Pay Scale** The estimated pay scale for a Senior Manager, Process Transfer, Development, and Validation role based in San Diego, CA, is $161,000 to $201,250. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! \#LI-DC1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 530785 **Type:** Regular Full-Time **Job Category:** Others