Specialist Quality Systems

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

The Q-Systems Specialist supports the Quality Systems team and the local Business Process Owner for key Quality Management System processes at the Schaffhausen site. The role contributes to compliant efficient and sustainable execution of Quality Systems processes including Change Control NC/CAPA Commitments Escalations Risk Assessments and related metrics. The position is expected to develop subject matter expertise in one assigned process area while maintaining active responsibilities and support across the other Quality Systems processes. The role provides process and system support end-user training review board and alignment meeting organization and continuous improvement input to strengthen compliance inspection readiness and user capability across the organization.

Essential Job Duties and Responsibilities

• Develop and maintain subject matter expertise for one assigned Quality Systems process while providing support process guidance system support governance input metrics review and continuous improvement contributions across Change Control NC/CAPA Commitments Escalations and related quality metrics.

• Provide day-to-day support troubleshooting coaching and training for end-users across relevant Quality Systems processes.

• Organize and support review boards and alignment meetings for relevant Quality Systems processes including process performance monitoring KPI reviews and timely follow-up on overdue or at-risk records.

• Support the local Business Process Owner in implementing global and local projects process enhancements and system improvements related to Quality Systems processes.

• Maintain active involvement in multiple Quality Systems processes including Change Control NC/CAPA Commitments Escalations and quality metrics with responsibilities assigned based on business needs and process priorities.

• Contribute to audit and inspection readiness as Quality Systems subject matter expert for the assigned process area and support other Quality Systems topics as needed.

• Maintain compliance with applicable company procedures GMP and regulatory requirements.

MinimumQualifications

• Bachelors degree in a scientific technical pharmaceutical engineering or related field or equivalent relevant experience.

• Relevant experience in a GMP-regulated pharmaceutical biotechnology medical device or similarly regulated environment.

• Strong understanding of Quality Systems processes with demonstrated experience in one or more related areas such as Change Control Non-Conformance CAPA Risk Assessments Commitment Records Escalations and quality metrics and willingness to develop into a subject matter expert for an assigned process area.

• Experience working with computerized quality management systems and supporting end-users in system or process-related questions.

• Strong verbal and written communication skills with the ability to interact effectively with cross-functional stakeholders.

• Ability to work independently with limited supervision manage priorities meet deadlines andmaintaina positive and solution-oriented mindset.

• Fluency in English; German language skills area plus with willingness to improve Germanproficiency.

OtherRequirements

• Team-oriented open-minded dynamic and highly motivated personality with strong interpersonal skills.

• Demonstrated flexibility social competence and ability to collaborate with stakeholders across different departments and levels of the organization.

• Ability to influence without direct authority andprovidepractical guidance in a regulated environment.

• Strong attention to detail and commitment to quality compliance and data integrity.

• Willingness to support audits inspections review boards and site or global initiatives as needed.

• Ability to handle diverse tasks and adapt to changing priorities in a fast-paced environment.

Application Note:

A motivation letter is notrequired. Applicants are asked to include a brief abstract in their CV explaining their motivation for applying for this position.

Required Skills:

Preferred Skills: