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 jnj.com.
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:
QualityJob Sub Function:
Multi-Family QualityJob Category:
People LeaderAll Job Posting Locations:
Schaffhausen, SwitzerlandJob Description:
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Objectives and Responsibilities
Has end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products.
Main Duties / Additional Duties / Sphere of Authority
Principal Duties:
Compliance with the GMP, EHS and SOX requirements and guidelines, as applicable. Serves as the single point of Global Quality contact for an assigned group of marketed products with medium to high complexity. Responsible for ensuring end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release. The Quality Owner (QO) knows the product history and understands the processes across the various manufacturing sites. The QO establishes and maintains site Quality contacts and drives communication with all Q&C stakeholders. Assures Quality milestones and Quality deliverables are achieved and approves content of spec changes to ensure spec changes are aligned end-to-end. Assure multisite/global/high level product CAPAs and change controls to ensure they are approved and closed appropriately.
Represents Global Quality on the Value Stream Teams (VST). Maintains the flow of communications between Global Quality and VST teams. Brings Quality issues to the VST and assists with prioritization of projects and with key product decisions. Supports the business continuity process including VST strategy and BCP projects. Reviews Proactive Product Quality Scans with the VST and assures appropriate mitigating actions are defined there. Prepares quality sections of Product Strategy and End-to-end Value Stream Mapping. Participates in the F2F VST meetings on PSR and VSM finalization and project prioritization. Aligns and interfaces the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
Accountable for all stability related activities of commercialized products including change management study management. Liaises with Product data specialists or Product quality specialists to gather input on stability topics (e.g. draft stability protocols and reports).
Collaborates with a Product Quality Specialist on regulatory questions related to stability and on preparation of regulatory PA inspections regarding stability topics.
Manages changes of shelf life / retest period and storage instruction.
Defines and oversees the necessary QA resources for global and local Q of his or her assigned products.
Leads a comprehensive Quality Sub team that assures Quality throughout, DS, DP, Fill Finish
& Device:
o Assures product quality over the life cycle, understands the performance, and risk profile, throughout shelf-life
o Ensures patients get the right quality products.
o Supports the sites, represents the sites on VS Team.
o Supports QA communication/issue resolution with External Manufacturers and
o Business Partners, as applicable.
Ensures standard Global Quality processes (risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality
o Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
o Supports preparation of the criticality analysis per schedule.
o Ensures complaints are well managed, issues are understood, and trends in Global Medical Safety, GMS are understood and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
o Coordinates and/or owner of complaints trend signal investigations.
o Partners with Quality Integrator to complete Transfer of Ownership activities.
o API, RM, FP specifications change approvals.
Presents project updates to QM for Global Quality alignment
o Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions. Participates and actively engages on IMTs. Supports field/recalls as needed.
Review/approval/support regulatory filings and answering questions from the agency during filing review.
Support agency audits for the product assigned.
· Demonstrate basic knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
· Gives inputs and provide guidance on production quality and packaging application related subjects.
Decision making and Problem Solving:
· Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
· Gives input to the development of new strategies and implements and deploys strategies.
· Aids in the creation of product portfolio guidelines on the control strategy for commercial
products which will influence the life cycle management strategy and the total quality cost during commercial production.
· Provides Quality structure, direction and decision making to the teams (Quality and VST) in situations of medium risk, uncertainty and ambiguity.
· Collaborate and support on the organization and transformation initiatives.
Innovation/Creativity:
Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs, thus providing the best total value to the company.
Deputy Arrangement (Active/Passive)
Active representation: the employee represents the following persons in case of absence. Passive representation: in absence, the employee is represented by.
Active representation: Other PQOs / Director PQM
Passive representation: Director PQM / Sr Director PQM.
The demands for the job position (education, skills, competencies) are archived by HR.
Leadership & Behavioral Competencies
· Experience in a successful leadership role in building, inspiring and managing a global team and influencing stakeholders across a matrixed organization structure.
· Well-developed leadership skills and the ability to influence others in a matrix environment.
· Excellent communication and organization skills required. Solid presentation, written and oral communication skills as well as the ability to meet deadlines. Strong attention to detail and analytical / problem-solving skills.
· Business oriented, independent and driven.
· Seeks, listens to, and incorporates diverse points of view (Connect)
· Courageously tries new things, test and learns from mistakes. (Shape)
· Develops self and others to reach their goals (Grow)
· Engages in open and honest conversations (Grow)
Education and Experience:
· Minimum 7 years of experience in quality, compliance or regulatory affairs in a regulated industry.
· Minimum of Master / Bachelor´s degree in a scientific discipline, but essential that the individual
has excellent scientific & technical capabilities based on combination of qualification and experience.
· Experience in more than one quality related disciplines is essential including, but not limited to,
manufacturing and packaging operations, analytical and micro testing and commercial distribution, basic knowledge of new product introduction.
· Demonstrate medium knowledge of financial management, budgeting and business case calculation.
· Fluent in English.
Required Skills:
Preferred Skills:
Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Risk Management, Standard Operating Procedure (SOP), Tactical Planning, Team Management