Manager Product Quality

at  Johnson Johnson

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 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 humanity. Learn more at https://www.jnj.com/.
Janssen Vaccines, Branch of Cilag International GmbH, a member of the Johnson & Johnson Family of Companies is recruiting for an Manager Product Quality, located in Bern, Switzerland.
The Product Quality Manager is responsible for ensuring that activities related to product manufacturing are compliant with applicable GMP requirements. With his / her team, the team leader will perform batch disposition related activities, support Operations for GMP readiness preparation, and support inspection activities.
Manager Product Quality (f/m/d), Location: Bern, Switzerland
Essential duties

People management:

• Manage and organize the workload within the Product Quality sub-team
• Lead and develop the team members including target definition and performance review
• Initiate and support the hiring and on boarding process for new staff
• Ensure that the training of the team members is relevant and performed on time
• Ensure that the team members are competent for the activities to be performed
• Defines relevant and adequate objectives for the team members, and measures performance
• Manage the team performance regarding the defined objectives, and escalate to the NCPQ Manager as appropriate

Technical duties

• Design strategies to ensure that quality requirements and business needs are met
• Supporting Operations in ensuring that a product is ready for being manufactured under GMP conditions (GMP readiness)
• Ensuring the quality of manufactured products meets the applicable GMP requirements
• On time disposition / preparation for disposition of manufactured products – Planning of the relevant activities
• Supports GMP-compliant production of active ingredients and drugs for clinical trials and market launch
• Verification and support for the disposition for QP release of manufactured batches and related documentation
• Support QA Laboratory & Material Management (LMM) team in releasing materials for Production (MfPs)
• Support Quality Operations and QA LMM in ensuring GMP readiness for NPI projects
• Supports the collection of KPIs to measure Quality and Operations’ performance
• Review and approval of non-conformances, CAPAs, and Change Controls
• Ensure the relevancy and effectiveness of corrective and preventive actions
• Contact person for production, development and quality control for compliance related topics
• Review and approval of process documents (e.g. SOPs, work instructions, process descriptions, etc.) and risk assessments
• Support the material creation activities in SAP
• Support for processing complaints
• Support for product escalation activities
• Support for internal and external audits as Subject Matter Expert
• Support the execution for risk management activities for the site
• Ensures that batch records’ documentation is stored and archived at adequate location and according to applicable requirements

Performance measurement

• Delivery on annual goals & objectives, guided by Our Credo and Leadership Imperatives
• Conformance to quality KPIs (QSMR, performance review)

QUALIFICATIONS

Required Qualifications

Education & Experience

• University degree in pharmacy, natural science, medicine, or equivalent
• At least 5 years of working experience in Quality department in pharmaceuticals, biotechnologies or chemistry industry

Skills & Competences

• Ability to design strategies to meet quality and business needs
• Good leadership capabilities – Able to manage a team of minimum 3 people
• Very good communication skills in both German and English language
• Excellent communication and teamwork skills
• Ability to work in a diverse and changing environment
• Flexibility, accuracy and reliability
• Ability to prioritize and to continuously review priorities

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

• Design strategies to ensure that quality requirements and business needs are met
• Supporting Operations in ensuring that a product is ready for being manufactured under GMP conditions (GMP readiness)
• Ensuring the quality of manufactured products meets the applicable GMP requirements
• On time disposition / preparation for disposition of manufactured products – Planning of the relevant activities
• Supports GMP-compliant production of active ingredients and drugs for clinical trials and market launch
• Verification and support for the disposition for QP release of manufactured batches and related documentation
• Support QA Laboratory & Material Management (LMM) team in releasing materials for Production (MfPs)
• Support Quality Operations and QA LMM in ensuring GMP readiness for NPI projects
• Supports the collection of KPIs to measure Quality and Operations’ performance
• Review and approval of non-conformances, CAPAs, and Change Controls
• Ensure the relevancy and effectiveness of corrective and preventive actions
• Contact person for production, development and quality control for compliance related topics
• Review and approval of process documents (e.g. SOPs, work instructions, process descriptions, etc.) and risk assessments
• Support the material creation activities in SAP
• Support for processing complaints
• Support for product escalation activities
• Support for internal and external audits as Subject Matter Expert
• Support the execution for risk management activities for the site
• Ensures that batch records’ documentation is stored and archived at adequate location and according to applicable requirement