Quality Validation Manager
The Quality Validation Manager has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Manager is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any revalidation studies are performed. The Validation Manager has responsibility for authoring and maintaining the Validation Master Plan for the Production and Quality Control areas of the site and support areas. As part of these responsibilities, the Validation Manager may author and execute validation protocols and validation reports or will review and approve the protocols and reports that are prepared by the validation team. In addition, the Validation Manager may be expected to support global manufacturing and distribution sites within the company as part of the Global Compliance Team.
- Responsible for crafting, maintaining and continually improving the validation system in line with current national and international standards.
- Responsible for implementation and ongoing improvement of validation policies and procedures within the company Quality Management System, along with providing technical expertise within those functional areas.
- Responsible for developing and implementing matrix type validations where applicable for processes and equipment with adequate supporting rationales.
- Responsible for oversight and execution of validations for production, manufacturing and cleaning processes.
- Designs, authors, and aids in the execution of validation protocols. Authors process validation protocols and report, along with developing and maintaining validation metrics.
- Responsible for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities, and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards. Maintain Revalidation Plan and all manufacturing, while ensuring all revalidation is performed and reported.
- Prepare and maintain Validation Master Plans for the facility, utility, and equipment to ensure they are all adequately validated for cGMP projects undertaken within the facility.
- Work with Design Engineering on Impact Assessments, GAMP and DQ assessments for all equipment with appropriate guidance from the Users and Quality Assurance.
- Make proposals and implement actions as part of the continuous improvement program.
- Lead all aspects of Production Operators and QC analysts during validation studies and present to Regulatory and Customer auditors
- B.A. or B.S. degree, preferably in life sciences field
- 8+ years applicable experience preferably in a pharmaceutical, biopharmaceutical or IVD industry
- 3+ years leadership experience, with project management experience
- Knowledge of cGMPs or equivalent regulations
- Ability to make sound decisions about scheduling, allocation of resources, and balancing priorities
- Strong digital literacy required: shown understanding of Minitab; functional knowledge of Microsoft Outlook, Word, and Excel.
- Proven knowledge and experience with software systems and integration with the quality system.
- Ability to analyze, investigate and propose approaches to technical and regulatory issues.
- Ability to craft, implement and analyze manufacturing process validation studies.
- Ability to implement the Validation Plans for medical device and related product manufacturing equipment and facilities.
- Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. The associate is exposed to a production environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud.
- Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
- Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.
- While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.
- Health care insurance (health, dental, vision, and prescription coverage plans)
- Spending and savings accounts: Healthcare savings, flexible spending & limited purpose flexible spending
- A generous amount of paid time off and paid vacations
- Short and long-term disability coverage
- Paid parental leave, 401k, stock purchase options
- And so much more!