\\n \\n Johnson & Johnson is currently seeking aSenior Manager Commercial Qualityto join our team located in Selzach, Switzerland.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 atPosition summaryThe position is accountable for the oversight and execution of Quality Management Systems and Compliance at the Selzach distribution centres and the Customer Service locations within the Distribution Center of Selzach.The Senior Manager Commercial Quality is required to be present on site preferably 4 days per week.The position:

• Supports Deliver Operational and Customer Service teams on Distribution and Transportation Quality related matters and liaises with multiple Quality organizations to drive timely resolution of Quality related issues.
• Defines and implements departmental strategies and services as the expert on distribution quality systems and quality management. In collaboration with Enterprise and other segment or enterprise quality organizations implements common distribution standards and Quality Management Systems (where appropriate).
• Optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations & J&J Enterprise standards, the quality vision and/or Policy, and provides a measurable impact to quality, cost, and customer value.
• Identifies & leads opportunities to continuously improve quality, cost and time factors, consistent with both Segment and Deliver business objectives.
• Understands current and emerging regulations and the impact to quality and distribution practices.
• Acts in the role of SELZACH DC Management Representative as per ISO13485/QMS definition

Essential duties and responsibilitiesQuality Site lead

• Quality responsible for the Selzach site.
• Leads and manages the Quality Selzach site and supply chain in order to assure safety, efficacy and timeliness of product supplied to patients.
• Management representative (ISO)

Audits & inspections

• Leads, supports and follows-up of internal and external inspections.
• Supports and actively participates to quality internal/external audits.
• Performs pro-active GAP analysis against applicable requirements and/or regulations and sets-up corrective actions to support business continuity.
• This includes audit preparation, audit completion and audit follow-up.

Change control:

• Initiates, assesses and/or approves Change Controls related to distribution activities and repackaging activities.

Documentation

• Writes, (periodic) reviews and/or approves Work Instructions (WI) and Procedures (SOP)
• Collaborates with other departments for documentation content and ensures Good Documentation Practices are followed.
• Archives quality documents and/or repack/relabel records following the record retention period and archiving system.

Improvement

• Provides data/information and leads the Quality Improvement Plan (QIP) and the Quality Management Re-view (QMR) meetings
• Supports and performs trend analysis and proposes corrective actions where needed.
• Reviews and improves processes of the QMS, ensures that KPIs are in place.
• Participates to the process improvement as process owner.

Non- conformities & Delivery Service Issues

• Initiates, assess, investigates, and/or approves Quality Issues, Corrective and Preventive actions and Delivery service issues related to distribution activities to avoid reoccurrences.
• Assesses if record is applicable for escalation and initiates appropriate process

Project

• Participates, follows up and/or leads development of projects implementation in collaboration with Operations, Region and/or Franchises
• Provides QA Team with project progress on a regular basis

QA on the floor

• Supports operations to work in compliance with GMP (where applicable) and GDP requirements
• Performs Gemba Walks on a regular basis
• Joins weekly operational kick-off
• Works actively and proposes operational improvements

Qualification & Validation \\xe2\\x80\\x93 Equipment & facilities

• Is involved in the periodic requalification of equipment or qualification of new equipment related to distribution

Risk management

• Identifies, prioritizes and mitigates quality risks related to QA and operational processes

Supplier Management

• Coordinates the supplier management activities (including suppliers\\xe2\\x80\\x99 approval and maintenance of compliant state).

Training & Qualification

• Delivers qualification to warehouse personnel to ensure operational personnel has an appropriate under-standing of the process/activity
• Assigns appropriate training towards teams

Management

• Manages the Quality organization in such a way that the short- and long-term objectives are met
• Manages, coaches and develops the team in reaching their quality, business and personal objectives
• Empowers and enables team; leads by example
• Performs regular follow-up to help, coach or to correct when necessary
• Is Responsible for training, supervising and performance management of staff
• Supports hiring
• Ensures adequate resources are available to support business needs
• Trains & develops staff in the execution of their technical and managerial functions
• Establishes and maintains effective working relationships internally and with operations, IT, engineer, purchasing, Q&C, franchises, BQ, etc. and ensures alignment of objectives and deliverables.
• Ensures all additional base business-related activities are performed or supported as per defined plan in the QA weekly team meeting or as agreed during the face-to-face meetings

QualificationsEssential knowledge and skills

• Higher education / Master\\xe2\\x80\\x99s degree
• Has been exposed to external inspections and/or JJRC audits
• Extensive QA related experiences within an operational regulated environment with focus on Distribution Center operation oversight.
• Experience as Project workstream lead.
• Knowledge of quality system processes such as Training, Document Management, Change Control, CAPA, Investigation, Audit and all QMS elements or local regulations.
• Analytical thinking, risk assessment, communication, managerial and leadership skills. Ability to assess mul-tiple issues, and interpret the compliance and business impact, translating into system and process re-quirements.
• Warehouse management system

Core competencies required for this role

• English, fluent
• German as a plus but not required
• Good knowledge of Microsoft Office applications (Word, Excel)
• Excellent communicator, ability to building a network and create win-win solutions
• Able to build strong relationship with internal and external customers
• Team player
• Able to negotiate and influence
• Problem solver \\xe2\\x80\\x93 structured & analytical way of working
• Result oriented
• Can work independently, knows the right priorities and escalates issues if needed.
• Excellent verbal and written communication skills
• Able to manage and coach a team

Special Requirements

• See above Refer to essential knowledge section.
• Current Good Documentation practices
• ISO 13485
• MDR

What we offerOur employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program supports your mental and physical well-being.Working at Johnson & JohnsonFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.A cover letter is not required for your application, but we kindly ask that you include a brief statement explaining why you are applying in your resume or CV. To ensure a fair recruitment process, please refrain from adding a photo in your CV.\\n \\n \\n \\n \\n \\n

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