PURPOSE AND SCOPE:

The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT department. This position is responsible for ensuring compliance with established processes, documentation, and controls to drive efficiency and quality in IT operations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Responsible for documentation management and archiving within the QMS framework.

• Conduct QMS administrative work, including maintaining records, tracking metrics, and facilitating audits.

• Design and implement DTI (Department of Information Technology) IT processes and controls, including IT Standard Operating Procedures (SOPs), Work Instructions (WIs), and systems.

• Identify training needs for DTI IT personnel to execute assigned QMS functions effectively.

• Develop training matrices and packages to support the qualification of IT personnel in implementing QMS processes.

• Develop change management strategies, including PowerPoint decks, and communication plans to facilitate smooth transitions within the IT department.

• Collaborate with cross-functional teams to ensure alignment of QMS processes with departmental goals.

• Support continuous improvement initiatives by analyzing data and identifying areas for enhancement within the QMS.

• Participate in QMS audits and inspections, addressing findings and implementing corrective actions as necessary.

• Stay updated on industry standards and regulatory requirements related to quality management systems in IT.

• Gained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)

• Understanding the method for the management of IT departments providing GxP system support/management

• Responsible for compliance in alignment with the defined QMS processes

• Responsible for the continuous improvement of the QMS framework

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

EDUCATION:

• Bachelor's degree in Computer Science, Software Engineering, a Science or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role

EXPERIENCE AND REQUIRED SKILLS:

• Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements

• 2+ years of professional experience working with or owning computer software validation/system coordination

• Additionally, minimum of 5 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred

• Experience of working in a company manufacturing under GxP environment

• Your work ethic is characterized by a strong self-motivated, systematic and analytical approach

• Pay close attention to details

• Strong communication and project management skills as well as a strong service and result oriented working style

• Good general Project & Program Management skills

• Must be a self-starter with strong creation to execution skills.

• The ability to troubleshoot and resolve system-related issues effectively.

• An enterprise wide mind-set – building productive working relationships

• Cultural sensitivity and understanding. Able to effectively deal with international/cultural differences.

• Excellent oral and written communication

• Ability to adapt to business strategy or changes in priorities

• Strong EN ISO 13485:2016 knowledge

• 21CFR Part 11 e-signature knowledge

• IT service provider/department process awareness

• GAMP 5 software validation knowledge

• Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc

• Knowledge of computer software validation and computer software assurance principals

• Knowledge and understanding of business systems, Windows Office, Teams, Projectplace, Visio etc Basic familiarity with the production of medical devices or pharma products

• high language proficiency in English

• German a benefit

• Willingness to be on site as needed

• Willingness to travel within Europe and in the US as needed to support projects.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.