Job Information
Cardinal Health Director, Validations in Topeka, Kansas
Position Summary
The Director, Validations is responsible for management and oversight of the validation program for Cardinal Health Nuclear and Precision Health Solutions (NPHS) facilities. Reporting to the Vice President of Product Development and Technical Operations, this position will coordinate within cross functional teams to define, administer, and continuously improve validation policies and procedures for new and existing cGMP systems, including facilities, systems, manufacturing equipment, testing instrumentation, and processes, across our network of nuclear manufacturing facilities. The position will be responsible for managing a team of validation specialists of varying experience levels to support both commercial operations and new product development.
With accountability for managing the validation requirements of various manufacturing and testing operations, this leader must understand and respond to business priorities and translate such requirements into tactical objectives and work direction for their managed teams. The individual must collaborate with peers in related line functions to ensure validated systems are configured to support technology transfer and routine production requirements, and that cross-functional organizations are appropriately aligned to support such business needs.
This role reports to the VP, Nuclear Manufacturing.
Responsibilities
Ensure a high degree of compliance of validated systems for commercial GMP manufacturing facilities.
Author, execute, review and summarize commissioning and qualification protocols for cGMP systems including facilities, utilities, manufacturing equipment, laboratory instruments, spreadsheets, computer systems and processes.
Develop and/or review master level validation plans for validation projects, qualification and validation of facilities, utilities, and equipment, as well as cleaning, sterilization, and manufacturing processes.
Author and/or review user requirement specifications for new equipment.
Provide general technical advice on new equipment and modifications to existing equipment to ensure validation/qualification status is maintained in a state of control
Provide both on-site and remote support to manufacturing facilities, and provide technical assistance to technicians and engineers
Participate in routine operations meetings and ensure that validated systems and processes remain within a state of control
Build solid cross-functional relationships with relevant internal and external departments necessary to ensure a cohesive approach to validation can be maintained
Manage and/or improve current validation procedures including protocols and reports, methods, and continuous improvement efforts
Establish key performance indicators in alignment with company and operational goals; maintain and report applicable department and system metrics
Stay abreast of industry trends in validation and expectations of regulatory agencies to improve the validation program
Act as SME for select topics during internal and external audits and inspections
Interface with external regulatory agencies as required
Develop validation staff members at varying levels of experience.
Qualifications
Bachelor’s Degree in Engineering or a Physical Science preferred; Advanced Degree preferred
Experience in a similar role at a pharmaceutical, biotechnology, or medical device company preferred
Demonstrated knowledge of FDA, ICH, and USP requirements related to the selection, qualification, calibration, and lifecycle management of utilities, facilities, process, and testing equipment systems used for pharmaceutical products.
Relevant, progressively responsible experience in a biotechnology, pharmaceutical, or radiopharmaceutical company.
Strong, clear experience working in matrix organizations.
Deep technical and scientific competencies across multiple modalities.
Strong ability to build, convincingly communicate, and execute strategic and operational plans.
Proficiency to prioritize and deploy resources rapidly to respond to changes in schedule, shifts in modality, and operational surprises, as well as build models for major areas of accountability and apply standard work wherever possible for efficient use of resources.
Exceptional interpersonal skills including the ability to influence behaviors and resolve challenges with poise, tact and diplomacy.
Strong leadership skills, with the ability to set direction, as well as inspire, motivate and mentor a cross functional team.
Exceptional oral and written communication skills to all employment levels, senior leadership, and external partners.
Excellent organizational, planning and implementation skills inclusive of business modeling. Ability to plan and manage department budgets to support finance and accounting requirements of the business.
Demonstrated knowledge and understanding of relevant compliance principals and requirements as applied to pharmaceutical products.
Demonstrated ability to analyze and extrapolate data, and hypothesize, plan and implement validation strategies.
A proven ability to operate effectively in a rapidly changing environment where analytical skills and agility are equally as important.
A self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment.
The ability to engender trust and respect quickly as a manager of people, with a priority for the development of staff. A capability builder at the organizational level.
An individual of unquestioned personal integrity who will be viewed as trustworthy both within the company, as well as with external relations.
Ability to travel up to 10%
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)