Senior Specialist Quality Systems 80-100%, fixed-term, 10 Month Req.: 2506231618W; Location: Sc[...]

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This position may represent Quality on APR/PQR (Annual Product Review/Product Quality Review) by being responsible for on time completion of APR/PQR activities, guiding, setting, and standardization of quality/compliance requirements, development of SOPs and providing practical solutions in collaboration with the APR/PQR process owner and contractor. This individual will comply with applicable regulations and meet the needs of the business and supply chain.

Responsibilities:

• Subject Matter Expert (SME) for APR/PQR quality systems processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas.
• Work in close collaboration with APR/PQR process owner and external contractor team. Provide overview or detailed proactive communications to process owner and global APR/PQR teams.
• Lead through the review and on time completion of APR/PQR by collaboration with cross-functional teams.
• Act as an SME on APR/PQR during inspections and audits.
• Conduct, execute and document thorough investigations and CAPAs, Audit responses.
• Ensure timeliness of results through independent, proactive intervention.
• Bring forward innovative process improvements to drive compliance and/or efficiency and implement improvements as part of the global APR/PQR community.
• Contribute to continuous improvement projects in regards to standardization and simplification.
• Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.
• Review and approve compliance records, procedures and other documents, as required by procedure.
• Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations.

Qualifications:

• A minimum of a Bachelor’s Degree is required, preferably in Engineering, Chemistry, Biology, Biological Sciences, or Food Sciences field.
• A minimum of five (5) years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, or Cosmetic Production is required.
• Alternatively, a minimum of a laboratory technician EFZ, preferably with HF certification and a minimum of seven (7) years of experience in and outside of Quality Control with increasing responsibility.
• Proven ability to lead and influence others with very good communication and presentation skills.
• Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.
• Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
• Demonstrated skills in Process Excellence preferred.
• Strong communication (verbal & written) and interpersonal skills, self-awareness, and flexibility required.

If you are a team-oriented, open-minded, dynamic, and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as needed.

Johnson & Johnson

Frau Jessica Horn

Sr. Talent Acquisition Partner

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