Cold Chain Technologies
Software Quality Validation Manager
Cold Chain Technologies, San Diego, California, United States, 92189
Cold Chain Technologies provided pay range
This range is provided by Cold Chain Technologies. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$90,000.00/yr - $105,000.00/yr Additional compensation types
Annual Bonus Job Title: Software Quality Validation Manager About Us: Cold Chain Technologies (CCT) is a leading manufacturer and provider of thermal packaging solutions to the pharmaceutical, biotech, health care and medical device industries. We are a technically advanced, financially secure company with more than 55 years of experience and a history of vigorous growth. CCT is ISO 9001 registered and is headquartered in Franklin, MA with a global manufacturing and distribution network including facilities in MA, TN, TX, PA, IL, CA and a global footprint in the Netherlands, United Kingdom, Spain, Brazil, Australia and India. Our affiliated design and testing laboratories are highly recognized throughout the industry as world-class. Job Description: The Software Quality Validation Manager will report to the Global Director of Quality.
This is a new role in the CCT organization and will require hands on testing as well as overall organizational development.
This role will oversee the quality and compliance of all CCT’s Digital Solutions by developing and implementing validation strategies, managing validation projects, and ensuring adherence to regulatory requirements and company standards. They lead teams, mentor staff, and collaborate with various departments to guarantee the reliability and effectiveness of software applications. Primary Responsibilities: Maintain a technical understanding of all integrated systems supporting the digital platform and how they impact the business go-to market strategy. Design and implement comprehensive validation strategies aligned with business objectives and regulatory requirements. This includes defining validation scope, objectives, and methodologies. Oversee the planning, execution, and completion of validation projects, ensuring they are completed on time and within budget.
This includes hands-on testing , managing resources
(both internal and offshore supplier partners) , timelines, and budgets. Ensure that all validation activities comply with relevant regulatory guidelines, such as those from the FDA and EU, as well as industry standards and company policies. Oversee the development, review, and approval of validation documentation, including plans, protocols, reports, and standard operating procedures (SOPs). Work with manufacturing sites to ensure that protocols are in place to support operators interact with the software applications. Monitor and analyze validation data, identify trends, and implement process improvements to enhance the efficiency and effectiveness of validation activities. Provide training and guidance to team members and other departments on validation of the best practices and regulatory requirements. Qualifications: Bachelor’s Degree with 5 – 10 years of experience; ideally in a related scientific discipline. Proven experience in leading and managing validation teams, with strong project management skills. Strong understanding of validation principles and practices, including software validation, process validation, and computer system validation. Extensive knowledge of regulatory requirements and guidelines, such as those from the FDA and EU. Experience with various testing tools and technologies, including test management systems and automation framework. Ability to effectively communicate technical information to both technical and non-technical audiences. Ability to meticulously document validation activities and ensure accuracy. Ability to analyze test data, identify issues, and develop solutions. Strong organizational and follow-up skills, Critical thinker with analytical proven problem-solving skills. Proven experience working with a global team. Effectively manage multiple and changing priorities. Ability to work in a very fast-paced environment. Experience working in a regulated industry, such as pharmaceuticals, biotechnology, or medical devices. Project Management (conducting status meetings, project reporting, etc) is a plus. Work related travel required – domestic and international (up to 25%) Preferred Qualifications:
Working knowledge of cGMP and GDP preferred Six Sigma Green Belt or Lean Certification Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing and Packaging and Containers Manufacturing Referrals increase your chances of interviewing at Cold Chain Technologies by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Software Quality Specialist” roles.
Junior Tester - Remote Work | REF#282385
Tijuana, Baja California, Mexico 1 month ago San Diego, CA $110,600.00-$218,500.00 17 hours ago Lender - Senior Software Quality Assurance Engineer (Automation/Manual Web Testing)
Sr Quality Engineer, Software - Design Controls
Staff Process Engineer/ Quality Systems Engineer - Remote
Design Quality Assurance Engineer II #6721
Tijuana, Baja California, Mexico 13 hours ago Sr. Quality Computer Software Assurance Engineer
Staff or Sr. System Test Engineer - LabView
NIWC - Undergraduate III / Graduate I - SAPEM Project (Task No. 56-125118)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
This range is provided by Cold Chain Technologies. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$90,000.00/yr - $105,000.00/yr Additional compensation types
Annual Bonus Job Title: Software Quality Validation Manager About Us: Cold Chain Technologies (CCT) is a leading manufacturer and provider of thermal packaging solutions to the pharmaceutical, biotech, health care and medical device industries. We are a technically advanced, financially secure company with more than 55 years of experience and a history of vigorous growth. CCT is ISO 9001 registered and is headquartered in Franklin, MA with a global manufacturing and distribution network including facilities in MA, TN, TX, PA, IL, CA and a global footprint in the Netherlands, United Kingdom, Spain, Brazil, Australia and India. Our affiliated design and testing laboratories are highly recognized throughout the industry as world-class. Job Description: The Software Quality Validation Manager will report to the Global Director of Quality.
This is a new role in the CCT organization and will require hands on testing as well as overall organizational development.
This role will oversee the quality and compliance of all CCT’s Digital Solutions by developing and implementing validation strategies, managing validation projects, and ensuring adherence to regulatory requirements and company standards. They lead teams, mentor staff, and collaborate with various departments to guarantee the reliability and effectiveness of software applications. Primary Responsibilities: Maintain a technical understanding of all integrated systems supporting the digital platform and how they impact the business go-to market strategy. Design and implement comprehensive validation strategies aligned with business objectives and regulatory requirements. This includes defining validation scope, objectives, and methodologies. Oversee the planning, execution, and completion of validation projects, ensuring they are completed on time and within budget.
This includes hands-on testing , managing resources
(both internal and offshore supplier partners) , timelines, and budgets. Ensure that all validation activities comply with relevant regulatory guidelines, such as those from the FDA and EU, as well as industry standards and company policies. Oversee the development, review, and approval of validation documentation, including plans, protocols, reports, and standard operating procedures (SOPs). Work with manufacturing sites to ensure that protocols are in place to support operators interact with the software applications. Monitor and analyze validation data, identify trends, and implement process improvements to enhance the efficiency and effectiveness of validation activities. Provide training and guidance to team members and other departments on validation of the best practices and regulatory requirements. Qualifications: Bachelor’s Degree with 5 – 10 years of experience; ideally in a related scientific discipline. Proven experience in leading and managing validation teams, with strong project management skills. Strong understanding of validation principles and practices, including software validation, process validation, and computer system validation. Extensive knowledge of regulatory requirements and guidelines, such as those from the FDA and EU. Experience with various testing tools and technologies, including test management systems and automation framework. Ability to effectively communicate technical information to both technical and non-technical audiences. Ability to meticulously document validation activities and ensure accuracy. Ability to analyze test data, identify issues, and develop solutions. Strong organizational and follow-up skills, Critical thinker with analytical proven problem-solving skills. Proven experience working with a global team. Effectively manage multiple and changing priorities. Ability to work in a very fast-paced environment. Experience working in a regulated industry, such as pharmaceuticals, biotechnology, or medical devices. Project Management (conducting status meetings, project reporting, etc) is a plus. Work related travel required – domestic and international (up to 25%) Preferred Qualifications:
Working knowledge of cGMP and GDP preferred Six Sigma Green Belt or Lean Certification Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing and Packaging and Containers Manufacturing Referrals increase your chances of interviewing at Cold Chain Technologies by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Software Quality Specialist” roles.
Junior Tester - Remote Work | REF#282385
Tijuana, Baja California, Mexico 1 month ago San Diego, CA $110,600.00-$218,500.00 17 hours ago Lender - Senior Software Quality Assurance Engineer (Automation/Manual Web Testing)
Sr Quality Engineer, Software - Design Controls
Staff Process Engineer/ Quality Systems Engineer - Remote
Design Quality Assurance Engineer II #6721
Tijuana, Baja California, Mexico 13 hours ago Sr. Quality Computer Software Assurance Engineer
Staff or Sr. System Test Engineer - LabView
NIWC - Undergraduate III / Graduate I - SAPEM Project (Task No. 56-125118)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr