Sr Quality Assurance Representative - Digital Compliance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific offers meaningful work, innovative thinking, and a culture dedicated to customer satisfaction. We contribute to finding cures, protecting the environment, ensuring food safety, and delivering COVID-19 solutions.

Location/Division Specific Information

The Computer System Quality Assurance Team provides quality oversight of business enterprise applications within the Pharmaceutical Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system lifecycle activities, and change management. We support a global business network, collaborating with Quality, IT, and business groups to support multi-functional projects and continuous improvement initiatives.

Discover Impactful Work:

An outstanding chance to work in a fast-paced environment, ensuring computerized systems operate compliantly and seamlessly to support worldwide pharmaceutical production and distribution.

In partnership with various IT groups and PSG sites, work to support computerized system compliance from system design, validation and verification, release, maintenance, change management, and retirement for Enterprise Systems.

A day in the Life:

• Provide support remotely or on-site, as requested, for specific Quality Assurance and digital compliance activities.
• Provide Quality Assurance oversight for PSG computerized systems for the entire system lifecycle from infrastructure qualification through application validation and maintenance.
• Review and approve required GMP records, ensuring compliance and procedural requirements are met.
• Drive the site use of the digital compliance global register to enable proactive IT Compliance oversight and actions.
• Analyze critical metrics to identify site, division and group trends. Communicate signals and trends to Senior Quality Leadership.
• External Regulatory Surveillance: monitor for new and revised regulatory requirements and industry trends. Interpret regulatory and compliance requirements and work with designated process owner(s) to ensure implementation into the Global Quality Management System and site processes.
• Participate in process improvement and digital transformation projects.
• Other duties as assigned.

Keys to Success:

Education

• Bachelor’s Degree (required) in Science, Engineering, or QA/Regulatory related field

Experience

• Experienced in implementing risk-based approaches to systems compliance and ensuring compliant deployment and utilization of advanced and emerging technologies, including machine learning, artificial intelligence, and data governance.
• 5 years experience in a GMP regulated industry, preferably pharmaceuticals, with direct experience in Validation or Quality Assurance.

Knowledge, Skills, Abilities

• Knowledge of FDA/EMA regulatory requirements applicable to computerized systems used for pharmaceutical production. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Understanding of the lifecycle phases for IT systems: development, maintenance, compliance management, decommissioning, and risk management.
• Strong interpersonal and communication skills: written and oral.
• Ability to collaborate with contractors and internal technical groups regarding IT compliance and Quality issues across a network of global sites and multiple time zones.
• Assertive assurance of Quality throughout all operations and the ability to make key decisions.
• Drive operational excellence with a continuous improvement mentality.

Physical Requirements / Work Environment

• Proficient with computer (MS Office Suite) and internet skills with a solid understanding of controlled documentation and data systems.
• Up to 25% domestic and/or international travel may be required.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations in the application process. For instance, this helps individuals with hearing, vision, mobility, or cognitive impairments.

• This phone line helps job seekers with disabilities needing assistance in job application.