Validation manager job description

Red Lion Road-PA002

Position Title: Validation Manager, Commercial

Reports to: Director of Validation

Location: Philadelphia, PA

This position is responsible for site packaging equipment qualification and product packaging validation, utilizing established validation process, approach, and protocol and report standards. Also responsible for new product cleaning assessments, cleaning validation, validation of cleaning and sterilization systems, and Environmental Monitoring.

This position provides technical and project support to Validation, Business Unit, Project Management, Engineering, Quality Assurance, and to our Customers to remain in a state of compliance.

The successful candidate will have supervisory responsibilities and be capable of manage multiple projects under limited supervision. Collaborates with and serves as a back up to the Validation Manager, Infrastructure.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Validation Manager, Commercial will lead the business beyond of the normal scope of task-based project validation. Knowledge, experience, personal drive, and creativity will motivate this individual to present new ideas to senior management that will affect the direction of the organization over the next years. The job duties and responsibilities associated with this position are as follows:

* Site validation management of packaging equipment qualification and product packaging validation.
* Cleaning and Sterilization system validation
* New product and cleaning validation assessments
* Cleaning Certifications and/or Cleaning Validation, if required
* Environmental Monitoring program management
* Participate in daily business meetings and report against validation commitments
* Coordinate department resources to ensure validation tasks are managed and on track to meet project commitment dates
* Utilizes the established validation process, approach, and protocol and report standards
* Use of SmartSheets to manage information, resources, track projects, and deliverables.
* Innovation of validation processes and tasks
* Participate in global Validation Center of Excellence and harmonization
* Evaluate validation trends in the pharmaceutical and contract packaging industries
* Lead gap assessments and remediation
* Support Regulatory, Customer and Internal Audits
* Collaborate with Director, Validation and Validation Manager, Commercial to evaluate business needs and determine Validation strategy for equipment, processes, cleaning, serialization, etc
* Review and approve Validation templates and validation related protocols and reports.
* Review and approve Requirements Specifications and Engineering Studies
* Support Change Control and CAPA process
* Serve as a back up to the Validation Manager, Infrastructure
* Limited travel may be required (less than 5%)

SUPERVISORY RESPONSIBILITIES:

* Lead a group of up to five or more team members.

Since 1973, East West Bank has served as a pathway to success. With over 120 locations across the U.S. and Greater China, we are the premier financial bridge between the East and West. Our teams of experienced, multi-cultural professionals help guide businesses and community members on both sides of the Pacific looking to explore new markets and create new opportunities, and our sustained growth and expertise in industries like real estate, entertainment and media, private equity and venture capital, and high-tech help build sustainable businesses and expand our associates' potential for career advancement.

Headquartered in California, East West Bank (Nasdaq: EWBC) is a top performing commercial bank with an exclusive focus on the U.S. and Greater China markets. With a strong foundation, and enterprising spirit and a commitment to absolute integrity, East West Bank gives people the confidence to reach further.

East West Bank is seeking a Model Validation Manager to join the Bank's Model Risk Management (MRM) group. The Sr. Model Validation Manager will be responsible for helping the team to maintain, improve and execute the Bank's MRM framework, standards, and processes. This will include performing model assessment, leading independent model validation projects, ongoing model risk maintenance related tasks, and model validation finding management and closure evaluation.
+ Lead model validation projects

+ Manage ongoing model risk management activities such as quarterly model certification process, annual model review process, model inventory update, model validation finding management and closure evaluation

+ Support regulatory exams, internal and external audits

+ Promote best industry model risk management practices throughout the company including China and Hong Kong subsidiaries

+ + Master's degree in quantitative field such as mathematics, statistics, economics, or financial engineering

+ 10+ years of experience in statistical analysis, model development, or model validation

+ 10+years of experience in financial industry, a plus

+ Extensive experience in writing strong model documentation

+ Proficient in mathematics, statistics, and statistical modeling techniques

+ Knowledge of financial products and/or quantitative modelling in the financial industry

+ Proficient in programming, such as, SQL, R, and Python

+ Highly proficient in MS Office applications

+ Intellectually curious, self-motivated with strong interests in modeling techniques

+ Excellent analytical, verbal, written, interpersonal communication skills with a strong attention to detail and accuracy

+ Ability to work both independently, lead assigned projects and in a team-orientated, collaborative environment

+ Detail oriented, results driven, and able to balance priorities in a dynamic environment

+ Excellent work ethics


Street: 135 N Los Robles Ave

Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Overview

This position is responsible for Validation activities (i.e. included but not limited to Manufacturing and packaging equipment qualification, Process validation activities, Cleaning and Sterilization validation activities), that supports commercial and new R&D drug development activities in support of Renaissance's specific client projects involving all delivery systems manufactured in Lakewood, NJ plant.

This highly technical and highly specialized position is responsible for generating, reviewing and approving protocols, deviations and reports; as well as scheduling manpower activities, providing internal and external customer feedback, ensuring on-time delivery of milestone activities, project staffing, and overall supervision of direct reports. The individual will be a Subject Matter Expert (SME) expected to oversee the overall validation activities related to the support of commercial manufacturing of pharmaceutical products.

This position will also interact frequently with regulatory/compliance personnel at Renaissance. It will assure compliance to all FDA and international regulations with regard to validation activities. The employee in this role must be able to represent Renaissance with customers and senior management.

Carry out team lead / team oversight responsibilities in accordance with the organization's policies. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Responsibilities

• Manage variety of complex issues in associated projects, plans and schedule project implementation. Responsible for defining scope of work for functional team.
• Manage, identify, hire, develop and recognize technical staff; the team may include senior level validation engineers, junior level validation engineers and technicians. Provide technical direction.
• Review and approve complex design concepts and analysis of technologies that incorporate own area of expertise as well as multiple disciplines, as applicable.
• Responsible for policy setting and defining procedures for the staff in accomplishing and documenting projects. Provides input on overall department policy.
• Aligns team goals with organizational goals, as well as projects/activities and refining those projects and/or activities proactively.
• Partner with project managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management. Schedule, plan, manage, and deploy resources to support validation activities and efforts, as needed, to ensure Renaissance and customer timelines are met.
• Provides leadership to assess and provide guidance and risk assessments regarding validation and compliance requirements in own area of expertise.
• Assist and guides the strategy and requirements of how validation is to be accomplished.
• Approves protocols and support documentation.
• Primary subject matter expert in audits and regulatory agency inspections. Prepares regulatory submissions and presents validation dossiers to regulatory authorities during routine internal, customer, and regulatory inspections.
• Applies specialized knowledge in a creative way to a broad range of difficult problems.
• Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
• Leads large-scale projects or several small projects with complex features.
• Builds cross-functional networks and effectively influences key stakeholders to advance department and corporate objectives
• Stay current with applicable regulations and industry practices. Provide updates to business areas and update procedures and practices accordingly to align with current regulations and industry standards from FDA, ISO, EMA and any other applicable domestic and international regulation.
• Provide guidance and technical expertise in following areas of validation -
o Sterilization and aseptic processing validation.
o Cleaning validation of manufacturing equipment.
o Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
• Develop statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions.
• Review and approval of Master Batch Records. Ensure content of batch records meet the validated state of the process.
• Provide technical assistance for investigations into process/product issues in support of the validation deviations and review of design requirements for products and or equipment.
• Generate and maintain the site program plans and validation master plan.

Qualifications

Master of Science degree in a pharmaceutical sciences, pharmaceutical manufacturing or other related field required. Bachelors with relevant experience might be considered.

Minimum two (2) years' relevant experience performing and managing validation activities within an aseptic pharmaceutical environment is required.

Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.

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