TOLMAR
Description
Core Hours
Monday - Friday, 8:00 am - 5:00 pm
Purpose and Scope
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.
Essential Duties & 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 a 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. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
Perform other related duties as assigned.
Knowledge, Skills & Abilities
Solid understanding of FDA validation guidelines and industry best practices and be able to implement validation standards on a daily basis.
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.
Proficient knowledge and understanding of validation requirements.
Knowledge and understanding of aseptic operations requirements.
Effective organizational and project management skills.
Effective troubleshooting and problem-solving skills.
Strong conflict resolution and decision-making skills, with the ability to address employee issues professionally and effectively.
Ability to delegate tasks appropriately, set clear expectations, and hold team members accountable for deliverables.
Proven skills in managing major Validation projects.
Core Values
This position is expected to operate within the framework of Tolmar's Core Values:
Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Education
& Experience
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.
Working Conditions
Working conditions include general office environment, laboratory and manufacturing settings (clean rooms where gowning is required)
Business demands may require working extended hours.
Compensation and Benefits
Pay: $125,000 - $150,000 depending on experience
Bonus eligible
Benefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Core Hours
Monday - Friday, 8:00 am - 5:00 pm
Purpose and Scope
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.
Essential Duties & 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 a 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. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
Perform other related duties as assigned.
Knowledge, Skills & Abilities
Solid understanding of FDA validation guidelines and industry best practices and be able to implement validation standards on a daily basis.
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.
Proficient knowledge and understanding of validation requirements.
Knowledge and understanding of aseptic operations requirements.
Effective organizational and project management skills.
Effective troubleshooting and problem-solving skills.
Strong conflict resolution and decision-making skills, with the ability to address employee issues professionally and effectively.
Ability to delegate tasks appropriately, set clear expectations, and hold team members accountable for deliverables.
Proven skills in managing major Validation projects.
Core Values
This position is expected to operate within the framework of Tolmar's Core Values:
Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Education
& Experience
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.
Working Conditions
Working conditions include general office environment, laboratory and manufacturing settings (clean rooms where gowning is required)
Business demands may require working extended hours.
Compensation and Benefits
Pay: $125,000 - $150,000 depending on experience
Bonus eligible
Benefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.