Director of Validations Job at Raland Compliance Partners
Directs and Manages the Validation Department. Supports company projects by providing
resources to support them, managing the strategy and direction for required resources to ensure
projects are delivered successfully and timely. Maintains validation program in compliance with
regulatory and industry standards. Directs and monitors all validation activities and supports all
regulatory and customer audits as the subject matter expert for validation.
ESSENTIAL DUTIES & RESPONSIBILITIES Primary duties performed, either unassisted or with
reasonable accommodation. Not meant to be an all inclusive list nor prevent other duties from being
assigned as necessary.
policies and practices.
EDUCATION, PRIOR EXPERIENCE, AND TRAINING
Minimum education, experience, licenses/certificates
normally required to perform duties of this position.
normally required to perform duties of this position.
resources to support them, managing the strategy and direction for required resources to ensure
projects are delivered successfully and timely. Maintains validation program in compliance with
regulatory and industry standards. Directs and monitors all validation activities and supports all
regulatory and customer audits as the subject matter expert for validation.
ESSENTIAL DUTIES & RESPONSIBILITIES Primary duties performed, either unassisted or with
reasonable accommodation. Not meant to be an all inclusive list nor prevent other duties from being
assigned as necessary.
- Maintain the validation program, procedures, etc. for all commissioning and validation
- Assure that all validation is performed to conform to company’s and cGMP requirements.
- Provide oversight for validation support to internal customers such as Technical Services,
- Provide direction from validation for process improvement and scale up projects.
- Ensure that client specific validation projects are managed appropriately.
- Provide technical support to Manufacturing – troubleshooting and resolving process related
- Identify process improvement opportunities and equipment needs for
- Support deviation investigations and implement CAPA based on validation changes.
- Perform all job responsibilities in compliance with applicable regulations, standard operating
- Support Core Values of Quality, Service, Collaboration, and Courage.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business
policies and practices.
- Perform all other tasks, projects, and duties as assigned.
EDUCATION, PRIOR EXPERIENCE, AND TRAINING
Minimum education, experience, licenses/certificates
normally required to perform duties of this position.
- Minimum of a bachelor’s degree in Life Sciences, Engineering, or related field is necessary.
- Management experience with emphasis on personnel training, development and mentoring,
- Project Management experience.
- Must have knowledge of ISPE Baseline Guides for Commissioning and Qualification and
- Minimum 15 years related work experience in pharma, biopharma, and/or biotech, with
- Previous management experience required.
normally required to perform duties of this position.
- Identifies trends/opportunities and develops strategies for implementation of organization
- Participates and provides strategies with regards to long-term planning
- Ability to interpret and relate Quality and Best Practice Qualification and Validation
- Develops ideas/plans for how to achieve vision of Executive Management.
- Directs managers and/or senior managers to execute plan
- Portrays appropriate levels of integrity and professionalism.
- Excellent written, verbal and presentation skills; Ability to communicate effectively with
- Results oriented and efficient; Acts with a sense of urgency.
- Has demonstrated ability to lead a cross-functional project team.
- Consistently/Frequently – see (vision), hear, ability to read and write, ability to interpret
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline focused, high-pressure entrepreneurial environment.
- Creative and open-minded who fosters an environment in which sharing of ideas is
- Ability to work closely with a diverse customer base (internally and externally).
- Ability to work well independently and in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
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