Description Johnson & Johnson is currently seeking a
Senior Manager Commercial Quality
to 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.
The 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.
Position Responsibilities 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.
Optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations & J&J Enterprise standards.
Identifies & leads opportunities to continuously improve quality, cost and time factors, consistent with both Segment and Deliver business objectives.
Acts in the role of SELZACH DC Management Representative as per ISO13485/QMS definition.
Essential Duties and Responsibilities Quality 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.
Audits & Inspections Leads, supports and follows-up of internal and external inspections.
Supports and actively participates in quality internal/external audits.
Performs pro-active GAP analysis against applicable requirements and/or regulations and sets-up corrective actions to support business continuity.
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.
Improvement Provides data/information and leads the Quality Improvement Plan (QIP) and the Quality Management Review (QMR) meetings.
Supports and performs trend analysis and proposes corrective actions where needed.
Non-conformities & Delivery Service Issues Initiates, assesses, investigates, and/or approves Quality Issues, Corrective and Preventive actions and Delivery service issues related to distribution activities.
Project Management Participates, follows up and/or leads development of projects implementation in collaboration with Operations, Region and/or Franchises.
QA on the Floor Supports operations to work in compliance with GMP (where applicable) and GDP requirements.
Performs Gemba Walks on a regular basis.
Risk Management Identifies, prioritizes and mitigates quality risks related to QA and operational processes.
Supplier Management Coordinates the supplier management activities (including suppliers’ approval and maintenance of compliant state).
Training & Qualification Delivers qualification to warehouse personnel to ensure operational personnel has an appropriate understanding of the process/activity.
Qualifications Essential Knowledge and Skills
Higher education / Master’s degree.
Extensive QA related experiences within an operational regulated environment with focus on Distribution Center operation oversight.
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.
Core Competencies Required for this Role
Fluent in English; German is a plus but not required.
Good knowledge of Microsoft Office applications (Word, Excel).
Excellent communicator, able to build strong relationships with internal and external customers.
What We Offer At Johnson & Johnson, we 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.
We are committed to creating an inclusive environment where diverse backgrounds, perspectives and experiences are valued.
Johnson & Johnson Family of Companies are equal opportunity employers.
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