Validation Manager Job Description
Validation manager
provides guidance and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy and quality systems for projects and/or strategic activities.
Validation Manager Duties & Responsibilities
To write an effective validation manager job description, begin by listing detailed duties, responsibilities and expectations. We have included validation manager job description templates that you can modify and use.
Sample responsibilities for this position include:
This individual works in conjunction with Validation Execution management, Validation Project Management, Manufacturing and Quality Assurance to manage program and strategies aligned with site validation philosophies
Maintain project activity/timeline/progress charts
Demonstrate strong understanding of 21 CFR 820, GHTF and ISO guidelines, in addition to the USP that governs the chemical testing
Providing insights and making value-added contributions towards the improvement of methodologies and processes
Accountable for data validation on all survey data
Assess model risks and limitations and make recommendations on remediation of model deficits
Provides leadership, feedback, mentoring, and work oversight for a team of analysts
Manages the Model Inventory to ensure the inventory is complete, accurate, and consistent with the intent of the Policy
Develops and maintains effective partnerships with the model developers, model owners, business-level risk management teams and auditors (internal and external)
Analyze identified issues for their impact on capital and other upstream and downstream processes or systems, escalating these issues to senior management
Validation Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Validation Manager
List any licenses or certifications required by the position: PMP, ASQ, CRCM, CIA, CISA, CQE, FRA, FRM, CFA, BB
Education for Validation Manager
Typically a job would require a certain level of education.
Employers hiring for the validation manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Computer Science, Chemistry, Statistics, Education, Mathematics, Life Sciences, Biology
Skills for Validation Manager
Desired skills for validation manager include:
Equipment
CGMP
GMP
ISO
Statistics
17025 and the IVD Directive
Econometrics
Model risk management regulatory guidance
Project
Quality management systems
Desired experience for validation manager includes:
Knowledge of analytical tools such as SPSS or SAS is desired but not required
Minimum 4 - 5 yrs model building experience
Master degree at a minimum
Ability to coordinate efforts across multiple business units and work with counterparts in Risk, Marketing, Finance and Treasury
Execute and document enterprise-wide credit risk systems validation with particular focus on wholesale, retail, and margin lending parameters (Probability of Default (“PD”), Loss given Default (“LGD”) and Exposure at Default (“EAD”)) used in both regulatory and economic capital
Develop and implement tools and methodologies required to underpin credit risk systems and parameters validation
Validation Manager Examples
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Validation Manager Job Description
Job Description Example
Our company is looking for a validation manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation manager
- Provide ODM test execution oversight and direction, execution of test audit, support for critical issue characterization and debug, understanding and maintaining issue tracking through the appropriate records database, and tracking project qualification progress and status for the HP R&D product development team and management
- Develops, trains and motivates Integration, Verification and Validation resources to ensure that adequate and qualified staff is available to perform and/or lead the validation and verification activities on the project/products
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, Tier 4’s
- Manage multiple projects while serving as a point of contact for validation program elements
- Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Board Of Health (BOH) inspectors and auditors
- Work collaboratively with Automation/Information Technology, Manufacturing, Manufacturing Engineering and Quality
- Develop and lead a high performance team responsible for the validation lifecycle program, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition
- Establish and communicate high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time
- Develop annual operating budget/staffing levels and manages operation to achieve them
- Strong knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing
Qualifications for validation manager
- Provide insightful and robust analyses of credit risk systems including risk quantification validation
- Perform business oriented and judgment based model input data and parameter validation
- Provide support in Local Model Risk Management and Model Risk Governance activities for BI&GF
- Market Risk workgroups
- Work with other areas of Market Risk
- Certification in of Quality and Productivity Improvement Methodologies
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Validation Manager Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of validation manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for validation manager
- Provide support to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation
- Review and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes
- Be the Quality lead in the development of the Master Validation Plans, Project Plans, and Test Plans
- Provide guidance and oversee the maintenance of the validated state including requalification/revalidation of equipment and processes
- Be responsible for the delivery of the HP BIOS Firmware qualification through the planning
- Execute HP Commercial Desktop functional test process, in order to meet customer requirements while ensuring the highest quality Commercial products
- To provide for resource management, including organizing and developing staff, task assignments, performance appraisals, manpower forecasts within the group, preparation of job descriptions, job interviews, motivating, coaching and training
- Provides a professional, dynamic, cooperative and high achieving work environment for the staff
- For the professional development of staff within the department including creation and management of the department training plan, medium and long term resource planning / allocation
- Coaches the integration, verification and validation leads on technical, management and leadership
Qualifications for validation manager
- 5 years’ experience with loss forecasting or pricing models for credit-sensitive assets (mortgages, auto loans, credit cards, commercial lending)
- Prefer minimum of 1 years’ experience in quantitative/statistical analysis in model development or validation areas
- A minimum of 5 years of experience in Model Development with 3+ years of experience leading model validations and staff is required
- Hands on programming skills, particularly statistical and database modeling tools (SAS, MATLAB, Access/VBA)
- Hands-on experience with SAS and/or other sophisticated statistical model development tools is a must
- Familiarity with leading model risk management practices and applicable regulatory guidance
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Validation Manager Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of validation manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for validation manager
- Responsible to work within the SIS Support group and assist with QHSE (Oceaneering and Client) documentation control, equipment maintenance/ control and vehicle management
- Manage Validation Lifecycle for business including Change Control relating to Process, Equipment, Materials
- Support of AFTC5 V&V activities for delivery to Metrolinx USRC Project
- Provide quality support to the evaluation of software applications and firmware associated with computerized systems and equipment used in laboratories, clinical manufacturing and facilities/utilities
- Advise on test requirements, scope, and acceptance criteria as per project deliverables
- Review and approve development documentation for GMP compliance, business risk, and consistency
- All functions associated with recruitment and hiring process for EBOL Validation positions (full-time, part-time, temp, Limited Term)
- Develop and maintain CS validation lifecycle maintenance including validation documentation, hierarchy, management of the revalidation/periodic assessments
- Lead and manage validation contractors on large scale projects to ensure the calibration, commissioning and qualification goals of quality, schedule and cost are met
- Complaint management, responsible for the management of complaint process within Packaging MPU
Qualifications for validation manager
- Proficient in relevant programming languages such as C/C++ and VBA
- Industry experience in model development or validation within a similar role is a plus
- Fast learner who grasps complex concepts and techniques quickly and works independently
- Proficient in relevant programming languages such as SAS, R, and Matlab
- Other industry certifications or credentials will be assets
- Industry certification or creditials will be asset
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Validation Manager Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of validation manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for validation manager
- Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections
- Develop and approve cGMP documents including, but not limited to, Master Validation Plans, SOPs
- Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements
- Review of equipment specification/design/procurement/installation and validation
- Project planning and execution including scheduling, task management, milestone planning and reporting
- Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports ) and Standard Operating Procedures
- Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc)
- Employee will be required to work closely with the Oceaneering training team at Stockton, Global SIS Management and SIS Engineers to develop an in-house training and competency courses for all grades of technicians
- Maintaining the validation sample diary, assessing the requirements for sample acquisition and coordinating validation projects
- Actively promote research and development, attend technology fairs/ forums and provide feedback internally
Qualifications for validation manager
- Industry certification or creditials will be an asset
- 5+ years’ experience in consumer credit risk modeling and analysis
- Proficiency with statistical and data software languages and packages
- Direct experience with Board Of Health (BOH) Inspectors, External Auditors
- Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems custom software projects
- This position requires at least 5 years Quality Management experience at a senior level within a fast paced food manufacturing environment
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Validation Manager Job Description
Job Description Example
Our company is growing rapidly and is looking for a validation manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for validation manager
- Provide support in estimating work effort for bids and preparation of work package descriptions for Safety Works required by a project
- Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required
- Participate in audits of internal and external system providers for GxP compliance as required
- Management of validation staff that provides oversight to, and executes, the validation program
- Assesses overall validation workload, staffs accordingly, and deploys resources to attain Engineering and production goals
- Manage staff and workload of at least one validation supervisor and 3 - 6 validation specialists and numerous contract validation specialists
- Development and implementation of strategy and policies related to Validation
- Represent the validation group and defend policies, program, and validation documentation during audits, regulatory inspections Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure
- Manage the process validation documentation process, through protocol generation, execution, and final approval
- To facilitate and participate in meetings and workshops as part of Continuous Improvement activities
Qualifications for validation manager
- Responsibility for the overall CAPA management system for the Cootehill facility
- Responsibility for the overall Validation management system for the Cootehill facility
- Coordinate Quality related programs such as QualEX and PoP
- This function plays a key role in investigation of high impact ER’s to ensure thorough investigation and root cause is identified
- Manage and oversee the plant validation process and ensure all validations are completed in a timely fashion
- This function will have responsibility to ensure the CAPA system is managed effectively and all plant investigations are carried out fully and appropriately