Job Information
J&J Family of Companies Manager Product Quality in Berne, Switzerland
Manager Product Quality - 2406213921W
Description
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.
Primary Location Europe/Middle East/Africa-Switzerland-Berne-Bern
Organization Janssen Vaccines AG (8851)
Job Function Quality Assurance
Req ID: 2406213921W