A Validation Manager is responsible for validating and coordinating the operations of machinery and process within the plant. Key responsibilities are listed on the Validation Manager Resume as – managing all operational validation activities within the organisation, developing and implementing a compliant validation strategy for the client, developing and implementing an efficient compliant and cost-effective calibration and maintenance program, managing the process for the creation of documentation and requirements, cleaning validation plans, and managing all facets of assigned validation projects as needed.
Skills and qualifications include the following – a good understanding and application of GMP and regulatory requirements, experience with a wide range of validations including computer system validation, equipment cleaning, and facilities validation plans. A Degree in fields such as science, engineering, or computer science is needed.
Objective : Dedicated Validation Manager with 2 years of experience in ensuring compliance with regulatory standards and quality assurance processes. Skilled in overseeing validation activities, conducting audits, and leading cross-functional teams to enhance operational efficiency. Committed to continuous improvement and fostering a culture of quality in pharmaceutical environments.
Managed a budget of $700K supporting 27 validation projects with zero variance.
Developed onboarding plans for new hires, enhancing team integration.
Lead validation activities for pharmaceutical and biotech products to ensure compliance with regulations.
Reviewed requirements, design, and test documentation for compliance.
Served as product owner for Agile projects, ensuring timely delivery.
Groomed requirements in Rally, training 200 users effectively.
Facilitated cross-functional collaboration to enhance project outcomes.
Experience
0-2 Years
Level
Entry Level
Education
B.S. Biology
Testing & Validation Manager
Resume
Objective : Results-oriented Testing & Validation Manager with 2 years of experience in executing robust validation processes and ensuring adherence to regulatory standards. Proficient in developing validation strategies, conducting audits, and collaborating with cross-functional teams to optimize quality assurance. Passionate about driving continuous improvement and maintaining high standards in pharmaceutical operations.
Ensured comprehensive documentation of test results, facilitating timely publication and regulatory compliance.
Proactively identified and resolved issues during testing phases, enhancing project efficiency.
Conducted extensive domestic and international site visits to oversee validation activities and process adherence.
Monitored team compliance with established ITMS processes and validation methodologies.
Advised team members on compliance requirements, ensuring alignment with Smart Controls standards.
Supported team development in ITMS methodology, fostering a culture of continuous learning.
Validated development processes to ensure controlled environments and robust evidence collection.
Experience
0-2 Years
Level
Junior
Education
B.S. Biology
Validation Manager Resume
Headline : Accomplished Validation Manager with 7 years of experience in the pharmaceutical and biopharmaceutical sectors. Expertise in leading validation activities, ensuring compliance with regulatory standards, and driving process improvements. Adept at managing cross-functional teams to enhance quality assurance and operational efficiency while fostering a culture of continuous improvement.
Modernized validation practices by integrating risk management based on GAMP standards, enhancing compliance.
Developed standardized templates that streamlined implementation processes, cutting time by 75%.
Oversaw a change control program, evaluating over 300 changes annually to ensure regulatory compliance.
Conduct risk assessments to identify and mitigate validation-related risks.
Established the IT Quality role within the IT organization to strengthen validation processes.
Managed an online accounting section, reviewing and supporting 60 drawings monthly for accuracy.
Eliminated redundancy between Operational Qualification (OQ) and Performance Qualification (PQ) scripts, reducing testing time significantly.
Experience
5-7 Years
Level
Senior
Education
BSc
Data Validation Manager
Resume
Summary : Strategic Data Validation Manager with 10 years of experience in leading validation processes and ensuring compliance with industry regulations. Proven expertise in developing and implementing validation strategies, conducting audits, and enhancing operational efficiencies. Passionate about driving quality assurance initiatives and fostering a culture of continuous improvement within cross-functional teams.
Skills : Validation Planning, System Testing, Data Analysis, Technical Writing, Process Improvement, Root Cause Analysis
Description :
Conducted thorough audits and assessments for validation protocols, ensuring compliance with current regulatory standards.
Produced validation deliverables in alignment with stringent computer system validation requirements.
Facilitated communication between system owners to expedite corrections based on audit findings.
Developed and maintained strong client relationships while overseeing regional validation activities.
Managed the validation section, resolving claims and ensuring prompt responses to issues.
Provided expert guidance to regional staff on complex validation challenges.
Reviewed and advised on validation and tax issues to ensure compliance with internal policies.
Experience
7-10 Years
Level
Management
Education
MSQA
Validation Manager Resume
Summary : Dynamic Validation Manager with a decade of extensive experience in regulatory compliance and quality assurance. Proven track record in developing and executing validation strategies, conducting audits, and leading diverse teams to optimize operational efficiency. Committed to fostering a culture of excellence and continuous improvement in the biopharmaceutical industry.
Skills : Validation Verification, Regulatory Compliance Management, Design Of Experiments, Statistical Process Control, Standard Operating Procedures, Regulatory Submissions
Description :
Ensure proper documentation practices are followed during validation activities.
Provided global validation support across the Novartis VampD network, ensuring consistency and compliance.
Facilitate change control processes related to validated systems.
Monitor industry trends and regulatory changes affecting validation.
Assist in the development of training materials for validation processes.
Led planning sessions and developed CampQ strategies and schedules for the MARS project in Marburg, Germany.
Designed validation strategies, ensuring adherence to validation policies and industry regulations.
Experience
10+ Years
Level
Executive
Education
M.S. Pharm. Sci.
Computer System Validation Manager
Resume
Objective : Proficient Computer System Validation Manager with 5 years of experience in ensuring regulatory compliance and quality assurance in pharmaceutical environments. Expertise in leading validation projects, developing protocols, and managing audits, while fostering collaboration across teams. Focused on enhancing operational efficiency and driving continuous quality improvements.
Skills : Change Control, Gxp Knowledge, Audit Management, Training Development
Description :
Led a team of scientists and engineers in Cleaning Validation (CV), Material Qualification (MQ), and quality improvement projects for biologics.
Established a QA Validation group responsible for developing, executing, and approving validation protocols and reports.
Participate in project meetings to provide validation insights.
Provided quality expertise to support Non-Conformance, Change Control, and Regulatory submissions.
Interacted with regulatory agencies and submitted responses to audits from multiple countries.
Participated as an internal auditor, supporting external inspection preparations.
Develop risk-based validation approaches for new technologies.
Experience
2-5 Years
Level
Consultant
Education
M.S. QA
Validation Manager Resume
Headline : Results-driven Validation Manager with 7 years of experience in the pharmaceutical sector, specializing in regulatory compliance and quality assurance. Proven ability to lead validation projects, implement effective processes, and enhance operational efficiency. Committed to fostering a culture of quality and continuous improvement across cross-functional teams.
Skills : Validation Methodologies, Communication Skills, Equipment Qualification, System Validation, Validation Strategy, Capa Management
Description :
Led a team of six in planning and executing comprehensive site validation activities.
Lead validation projects from initiation to completion.
Facilitated the cross-functional Validation Change Review Board to ensure compliance.
Managed validation for various products including aseptic ointments, tablets, and inhalers.
Guided the department through a cultural transformation to a high-compliance environment.
Expanded department from one to six employees, enhancing capability and output.
Developed a cost-effective, risk-based change control process that improved efficiency.
Objective : Results-driven Manufacturing Operations & Validation Manager with 5 years of experience in spearheading validation initiatives and ensuring compliance with regulatory standards. Adept at leading cross-functional teams to enhance operational efficiency and implement continuous improvement strategies within manufacturing environments.
Oversaw the installation, commissioning, and qualification of a multi-product facility, ensuring compliance with FDA and EU standards for aseptic processes.
Directed performance qualification for manufacturing processes, optimizing workflows and ensuring product quality.
Managed the aseptic process simulation media fill program, achieving zero contamination incidents during validation.
Led the Change Control Committee, reviewing and approving changes to ensure regulatory compliance and operational efficiency.
Coordinated validation and revalidation of all changes to CMO processes, ensuring alignment with internal and external standards.
Supervised a team of engineers and scientists for validation of equipment and processes, enhancing collaboration and efficiency.
Developed training programs for staff on validation processes, fostering a culture of quality and compliance.
Experience
2-5 Years
Level
Senior
Education
B.S. Eng.
Validation Manager Resume
Summary : Accomplished Validation Manager with a decade of experience in the FDA-regulated industries, specializing in compliance and quality assurance. Expertise in developing validation protocols, leading audits, and driving process improvements. Proven ability to enhance operational efficiency and foster a culture of quality within cross-functional teams.
Skills : Process Validation, Quality Management Systems, Quality Control, Continuous Improvement, Statistical Analysis, Attention To Detail
Description :
Oversaw the Fill Finish group change control program ensuring compliance with all regulatory requirements.
Identified and mitigated sources of microbial contamination, leading to a successful remediation plan for aseptic filling processes.
Managed the EOGAMMA revalidation program, ensuring timely completion and adherence to quality standards.
Coordinated facility production schedules to align with routine revalidation efforts.
Maintained the group’s Overall Equipment Effectiveness (OEE) program to optimize operational performance.
Submitted and monitored annual validation group budgets to align with strategic goals.
Initiated and led investigations into deviations, implementing corrective actions to mitigate product impact.
Experience
7-10 Years
Level
Management
Education
M.S. QA
Validation Manager Resume
Objective : Proactive Validation Manager with 2 years of experience in implementing validation protocols and ensuring compliance with industry standards. Adept at managing validation projects, conducting risk assessments, and collaborating with cross-functional teams to enhance quality assurance. Focused on improving operational efficiencies and fostering a culture of excellence in the pharmaceutical sector.
Skills : Validation Protocol Development, Team Leadership, Documentation Control, Industry Standards, Supplier Qualification
Description :
Established and executed a comprehensive Risk-Based Validation Program, including Validation Master Plans and SOPs for critical systems.
Designed a centralized validation documentation portal to enhance information sharing and team collaboration.
Executed comprehensive testing plans for equipment and processes, ensuring compliance with all regulatory requirements.
Led the validation process for new equipment installations, ensuring timely qualification and compliance.
Mentored junior engineers in validation practices, fostering skill development and knowledge transfer.
Implemented industry best practices for validation processes, driving improvements in quality assurance.
Collaborated with project teams to ensure alignment on validation requirements and timelines, enhancing project outcomes.
Creating an account is free and takes five seconds.
You'll get access to the PDF version of this resume template.
Choose an option.
Sign up with Google
Sign up with Facebook
Sign up with Linkedin
This helps us make sure you're human and prevents spammers from abusing our services.
By continuing, you agree to our Privacy Policy and Terms.
Unlock the Power of Over 10,000 Resume Samples.
Take your job search to the next level with our extensive collection of 10,000+ resume samples. Find inspiration for your own resume and gain a competitive edge in your job search.
Get Hired Faster with Resume Assistant.
Make your resume shine with our Resume Assistant. You'll receive a real-time score as you edit, helping you to optimize your skills, experience, and achievements for the role you want.
Get Noticed with Resume Templates that Beat the ATS.
Get past the resume screeners with ease using our optimized templates. Our professional designs are tailored to beat the ATS and help you land your dream job.
