Senior Specialist Quality Systems

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, 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 humanity.

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Quality

Quality Systems

Professional

Schaffhausen, Switzerland

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 business partners and global teams. This individual will comply with applicable regulations and meets the needs of the business and supply chain.

• Process Owner and 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 business partners and global teams. Provide overview or detailed proactive communications to APR/PQR business partners and global teams.
• Lead through the review and on time completion of APR/PQR by collaboration with cross-functional teams.
• Facilitate and provide feedback for APR/PQR automation projects and contribute to shaping an automated process.
• 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 regarding 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.

• 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, 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.

• Agility Jumps
• Analytical Reasoning
• Analytics Dashboards
• Coaching
• Collaborating
• Communication
• Compliance Management
• Data Compilation
• Data Quality
• Data Savvy
• Document Management
• Problem Solving
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Services
• Quality Standards
• System Audits
• Systems Analysis