The QA & Validation Manager will be responsible for managing the validation team, coordinating change control, preparing and issuing product quality reviews, updating and issuing the product quality manual and the site master file, and supporting international inspections.The position currently has 4 direct reports, plus 2 contractors who are responsible for the validation and qualification activities at the Lenexa campus.

This position reports to the Director of Quality & Regulatory Affairs

Validation Responsibilities

Manager for the Validation Team

Maintain the Validation Master Plan

Approval of the validation schedule

Review and approve validation protocols and reports

Quality Assurance and International Compliance

Manage the Change Control program and Coordinate Change Control board meetings

Manage the CAPA and responses associated with International inspections

Determine the schedule and preparation of Product Quality Review of products for International compliance

Maintain the Site Master File

Maintain the Site Quality Manual

*Shape solutions out of complexity - Is open and curious of other's perspectives. Organized analytical thinker with high level of energy

*Client focus - Has in mind client's satisfaction

*Collaborate with empathy - Has a positive attitude towards collaboration

*Engage and develop - Clarifies short-term directions. Demonstrates continuous leadership ability and qualities.

*Drive ambition and accountability - Proactively manages own and others work. Self-motivated and can work with minimal supervision

*Influence others - Communicates transparently

*Decision Making - Make decisions that have impact to multiple departments and facilities

*Aseptic Procedures - Knowledgeable regarding aseptic techniques and best practices for prevention of contamination in biological production systems

*Computer Skills - Ability to create and manipulate database/documents/spreadsheets to support business relatedreports

*Problem Solving: Ability to consistently perform and deliver lasting results within ambiguous situations

*Collaboration /Teamwork - Displayed ability to build cross-functional teams that share information and achieve positive results throughout multiple departments and across multiple functions

*Science Application - Ability to proactively apply scientific concepts targeted towards continual process improvement

*Regulatory Knowledge - Experienced in compliance to 9CFR and other regulatory guideline documentation as required for the job duties

*Intermediate skills with databases and word processing programs, inventory management programs

*Understanding of root cause investigation, report writing and statistical analysis

Education: Bachelor's degree in a subject relevant to vaccine manufacture and/or validation is required, graduate degree would be preferred

Work Experience:Four or more years' experience in the biologics industry. Must have working knowledge of quality systems.Have a working knowledge of 9CFR and APHIS regulations. Experience with equipment and process validation and qualification as relevant for the pharmaceutical industry is a plus.

*Able to read, write legibly and communicate in English, and able to maintain focus for extended periods on the computer

*Ability to move between different areas and buildings as needed.

*Position is located at the Ceva Animal Health Lenexa campus

*Will be moving from multiple buildings on campus.

Minimal travel to support Validation efforts or attend factory acceptance testing as needed

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job.This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job.This job description is not an employment contract.Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.

*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

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