Manager Quality Validation

Tolmar • Windsor, CO

139d • $125,000 - $150,000

About The Position

The Quality Validation Manager is responsible for managing and providing oversight for projects and team members executing validation deliverables for all local manufacturing sites. Responsibilities include qualifications and validations of equipment, utilities, facilities, cleaning, and aseptic process simulations. The manager ensures compliance with local and regulatory guidelines and requirements are met.

Requirements

• Bachelor's Degree in scientific or engineering discipline required.
• Minimum of 8 years' experience in GMP industry in quality and/or validation.
• Minimum of 4 years' experience with aseptic processing, cleanroom operations and contamination control.
• Minimum of 2 years in a leadership or mentorship role required.

Nice To Haves

• Solid understanding of FDA validation guidelines and industry best practices.
• Ability to work independently with minimal supervision.
• Demonstrated ability to lead, motivate, and develop a diverse team of validation professionals.
• Organized and able to meet project deadlines.
• Proficient knowledge of cGMPs for aseptic processing and clean room manufacturing.
• Proven ability to create and revise procedures or documents.
• Excellent oral and written communication skills.
• Ability to work well with employees at all levels.
• Computer literacy in Microsoft Office programs, including Outlook, Word, Access, and Excel.
• Effective organizational and project management skills.
• Effective troubleshooting and problem-solving skills.
• Strong conflict resolution and decision-making skills.
• Ability to delegate tasks appropriately, set clear expectations, and hold team members accountable for deliverables.
• Proven skills in managing major Validation projects.

Responsibilities

• Provide leadership in a fast-paced production environment with high quality and regulatory standards; supervise the Validation Engineers.
• Provide direction, mentoring, coaching and development to team members to support personal growth, enhanced job performance and career satisfaction.
• Create, write, and update validation guidelines, policies and procedures.
• Maintain the site's comprehensive Validation Master Plan (VMP), covering facility, equipment, utilities, cleaning, and process validation.
• Support the sterility assurance program, including aseptic process simulation (media fills), and contamination control strategies.
• Review and approve risk assessments, deviation investigations, and CAPAs related to validation.
• Work with the quality, production, engineering, maintenance, and development departments to ensure that all required prerequisite documentation is appropriately developed.
• Track and provide technical direction to validation activities to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements.
• Review product transfer protocols and reports; design and develop validation strategies.
• Provide validation support to aseptic manufacturing, assess impact to product quality, and determine appropriate actions.
• Serve as quality reviewer and approver for validation protocols and reports; assist in development and execution as needed.
• Coordinate validations for equipment and/or processes with outside vendors.
• Ensure compliance with all applicable regulatory requirements (FDA, EMA, ICH, ISO) and serve as a subject matter expert (SME) during regulatory inspections and customer audits.
• Conduct and participate in investigative meetings relating to validation manufacturing test failures; assess impact of production deviations.
• Review and approve validation test protocols and final reports.
• Maintain up-to-date knowledge of cGMP regulatory issues, particularly pertaining to validation, and ensure that company validation policies and procedures are updated accordingly.
• Contribute to the development of departmental budget and monitor expenditures.
• Select, develop, and evaluate validation employees to ensure functional objectives are met.
• Manage the validation systems' periodic review and change control activities.
• Work closely with cross-functional teams to ensure compliance and maintain systems in a validated state.
• Collaborate closely with manufacturing, quality, engineering, and R D to ensure validation and sterility assurance activities align with production schedules and project timelines.
• Participate in required annual hazardous waste training.
• Respond to spills per the Chemical Spill Procedures.
• Perform other related duties as assigned.

Benefits

• Pay: $125,000 - $150,000 depending on experience
• Bonus eligible
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree