Manager, Validation Job Description
Manager, validation
provides advice on the regulatory framework and requirements to business units and ensure that regulatory requirements are met.
Manager, Validation Duties & Responsibilities
To write an effective manager, validation job description, begin by listing detailed duties, responsibilities and expectations. We have included manager, validation job description templates that you can modify and use.
Sample responsibilities for this position include:
Work closely with global regulatory and validation experts, to translate the knowledge and application into China market, feedback China needs for central prioritization
Initial responsible for developing and improving extractables/leachables documentation and testing
Drive for opportunities to interact with regulatory agency (CFDA) and biopharm
Develop and implement validation strategies for statistical and other quantitative models used in loss forecasting, stress, and capital calculations for retail portfolios
Assess the quality and risk of model methodologies, outputs, and processes
Plan and manage validation projects
Provide leadership, management and development within the validation team
Maintain validation philosophies and master plans required to drive the validation lifecycle of a fully automated biologics commercial manufacturing facility and clinical manufacturing facility
Responsibilities include oversight of validation lifecycle maintenance that includes establishment of validation document hierarchy, changeover management related to validation, and management of the revalidation/periodic assessment and cleaning monitoring programs
Responsible to deliver regulatory inspection readiness training, coaching and guidance to junior level staff and subject matter experts (SME) to ensure validation philosophies are well understood and represented to regulators
Manager, Validation Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Manager, Validation
List any licenses or certifications required by the position: PMP, ASQ, CRCM, CIA, CISA, CQE, FRA, FRM, CFA, BB
Education for Manager, Validation
Typically a job would require a certain level of education.
Employers hiring for the manager, validation 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 Manager, Validation
Desired skills for manager, validation include:
CGMP regulations
Company
Controlled documentation and data systems
Group and financial services industry
Organizational
Process innovation and service quality
Audit and technological changes pertinent internal and regulatory policy and procedural requirements to ensure audit integrity
Business
Business supported and the regulatory framework they operate in
Biochemistry
Desired experience for manager, validation includes:
Advanced mathematical skills and previous experience working as a quant with financial quantitative modelling and risk analytics
Exposure to AIRB parameter estimations, economic capital modelling, enterprise wide stress testing, and familiar with capital adequacy requirements
Strong knowledge in statistics/probability/applied math
Knowledge of data extraction and manipulation techniques is an asset
General knowledge across various risk / model types, including market risk, credit risk, operational risk
Be able to be independently deliver work assignments efficiently
Manager, Validation Examples
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Manager, Validation Job Description
Job Description Example
Our growing company is hiring for a manager, validation. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manager, validation
- Responsible for testing all customers’ samples and for special tests that cannot be performed in the test area
- Collaborate with manager to establish objectives, milestones, and timelines for completion
- Manage and administer all aspects of people processes related to the employee life cycle
- Monitor and control expenditures against the department budget
- Serve as member on various Governance Teams
- Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems
- Solves qualification issues using critical analyses skills
- Oversee validation group and projects
- Acts as the primary Validation contact source for vendors, the FDA, and sponsors
- Be BIOS qualification PM/Test Lead
Qualifications for manager, validation
- Familiarity with US Basel Requirements
- Familiarity with CCAR/DFAST stress testing
- Demonstrated knowledge of Extreme Value Theory (EVT), Copula Modeling, Monte Carlo simulations
- 3 years experience in CPU and/or chipset post-silicon validation and debug
- A minimum of 10 years model development and/or validation experience, with 15+ years experience being preferred
- Advanced degree in Statistics, Mathematics, Quantitative Finance, Econometrics, Physics, Computer Science (Master and above, Ph.D
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Manager, Validation Job Description
Job Description Example
Our company is growing rapidly and is hiring for a manager, validation. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, validation
- Leads problem solving efforts to effect positive change with respect to quality, costs, test cycle reductions and ease of test
- Leads in test efficiency improvement by looking at various strategies including Test Automation
- To provide for Planning and Re-planning, including the preparation of all artefacts required (estimates, schedules, estimates to complete, work breakdown structures and Test Plans, Test Procedures, Test Reports, traceability matrices) to deliver CENELEC compliant products
- Consistently deliver on key performance metrics, EHS metrics, Compliance, HPO and budget performance
- Reports to Senior Manager in Model Risk Management
- Perform independent model validations and effective challenge for models such as – PPNR forecasting/stress testing, deposit balance forecasting, regulatory capital, balance sheet/ALM, liquidity risk, valuation, economic capital, interest rate
- Maintain and follow independent model validation standards and procedures
- Manage the work flow of US/off-shore model validators
- Managing day-to-day activities of the Validation Group
- As needed, writes and executes protocols for IQ, OQ, and PQ validation for plant processes and utility support
Qualifications for manager, validation
- In-depth knowledge and understanding of finance, economics, and probability theories, and experience working with fixed income modeling, FTP, time series, regression, econometric modeling
- Proficiency in statistical and financial software such as QRM, SAS (or equivalent), SQL, Excel (and VBA)
- Ability to interact with all levels of the organization internal and external customers, and to communicate technical information to any audience
- Experience with Treasury in a financial services firm is preferred
- Additional exposure to other econometric and statistical models
- Advanced degree in Applied Math, Applied Statistics, Applied Physics, Engineering or Finance (PhD level education preferred)
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Manager, Validation Job Description
Job Description Example
Our company is looking for a manager, validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manager, validation
- Provide quality management oversight to the QA validation group
- Lead in the development, review and implementation of validation documents, quality and engineering procedures
- Initiate, review, and approve change controls/engineering change notices, investigations, discrepancies/deviations, and audit responses
- Be the QA Validation SME (Subject Matter Expert) to understand the critical aspect of product, component and labeling requirements
- Review and sign off on relevant documentation per the function
- Develop and implement validation strategies for statistical and other quantitative models used in loss forecasting, stress, and capital calculations
- Counsels employees about work performance
- Operation/ running of specialist school and continue to develop courses by creating working syllabuses for courses
- Achieve BINDT accreditation for awarding PCN Certification
- Create supplementary training and software courses for the candidates
Qualifications for manager, validation
- Strong knowledge in applied math/statistics, especically the derivative pricing model theory, conterparty credit risk modeling, market risk capital modeling
- Experience in market risk modeling including the valuation and capital models, or counterparty credit risk modeling is preferred
- Proficient computing skills required such as Matlab, C++, Python
- Master’s Degree in Statistics, Econometrics, Mathematics, Industrial Engineering, Operations Research, Financial Engineering, or Physics
- At least 5 years’ experience in quantitative analysis with Statistics, Econometrics, or Data Mining
- Doctorate in quantitative field including Statistics, Mathematics, or Economics
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Manager, Validation Job Description
Job Description Example
Our company is growing rapidly and is hiring for a manager, validation. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, validation
- Travel alone or as part of a team, to be self sufficient and organised in pre job preparation, execution and post job activities including reporting and file completion
- Initiate, review, or complete documentation as required
- Ensure validation is in compliance with 21 CFR part 11a and applicable guidance documents
- Provide final review and approval of all computer/non computer validations design and execution
- Ensure that the methodology used in qualification testing will thoroughly test and challenge
- Provide and monitor non-conformance results during the validation studies to determine acceptable remediation/corrective actions
- Coordinate the interface with IS organisations, contribute to the harmonisation of IS validation methodologies, and ensure compliance of the methodology with GxP regulations together with site Validation Experts
- Approve the validation documentation for global information systems (ITS) and local shop floor systems, including the assessment of their impact on product Quality, Patient Safety and Data Integrity
- Define and monitor the plan for data integrity and periodic review of computer systems for GxP compliance
- Review and approvals of Change controls, Corrective plan and deviations as required
Qualifications for manager, validation
- The position requires a high calibre professional with a proven track record in people management and experience in a high volume, high value environment
- Must be innovative with ability to overcome challenges and barriers introduce change into a fast paced manufacturing environment
- Must be able to discern potential food safety issues and proactively implement preventive controls where required
- Ability to effectively interface with Division QA, Engineering, Regulatory Affairs, Medical and technical organisations in complex Quality and Product Safety issues and product related queries and product launches
- Requires extensive background in CAPA and Validation within a high speed and high volume FMCG environment?
- Previous experience in validation, CAPA, engineering, chemistry, bio-chemistry and chemical composition alongside an understanding of new and emerging technologies to support this fast paced environment will deliver success within this role
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Manager, Validation Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of manager, validation. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for manager, validation
- Explore test / business opportunities by building new automation platforms
- Develop actuarial assumptions to use in pricing, reserving or actuarial modeling in support of business assumptions
- Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
- Support and liaise with Technical Services in relation to the tech transfer of products into the facility
- Responsible for cleaning verification/validation and the execution of the cleaning verification and validation programs
- Responsible for the implementation and execution of the process validation program and continuous process verification
- Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required
- Develop and own Validation department budget
- Measure the Validation team's performance against Key Performance Indicators
- Lead site preparation for regulatory audits with HPRA and FDA (and other) from a Validation perspective
Qualifications for manager, validation
- Strong knowledge in applied math/statistics and numerical method such as Monte Carlo simulation, Bi-Nomial Tree and numerically solving PDE
- Requires BS/BA in a scientific discipline with 5+ years of related experience in a cGMP environment
- The role will support and lead investigations involving High Impact ER’s and work closely with plant SME’s to ensure a thorough investigation is carried out identifying root cause
- This function must ensure preventative actions put in place are effective and effectivity reports reviewed and tracked accordingly
- The role must maintain and report quality metrics on a weekly and monthly basis as required
- Substantial years’ experience in an IVVQ role, ideally in from aerospace, train control, medical, nuclear or automotive