SENIOR MANAGER COMMERCIAL QUALITY

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.
nj.
om/ J&J MedTech is recruiting for a Senior Manager Commercial Quality to be located in Belgium – Courcelles and reporting to the Director Commercial Quality EMEA.
Overall purpose of job.
The function holder Ensures and supports Operations of European Distribution Center (DC Courcelles) in Good Distribution Practices in the warehouse Assists the Site Quality Head in implementing and maintaining Quality System DC Courcelles Works in line with Credo Values, Supply Chain and J&J Deliver Requirements Works in line with the J&J Safety, Health and Environmental principles Participates to the process improvement as process owner Essential duties and responsibilities.
Quality Site lead Quality responsible for the Courcelles site Leads and manages the Quality Courcelles 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 include audits preparation, audits completion and audits follow-up Change control Initiates, assesses and/or approves Change Controls related to DC 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 ensure 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 Review (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 · Assess 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 – 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’ 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 · 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 in order to help, to 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,...
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 Qualifications Essential knowledge and skills.
· Higher education / Master’s 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 multiple issues, and interpret the compliance and business impact, translating into system and process requirements Warehouse management system Core competencies required for this role.
· Good knowledge of French and English languages · Good knowledge of Microsoft Office applications (Word, Excel,…) · Good knowledge of Good Documentation Practices Excellent communicator, ability to building a network and create win-win solutions · Ables to build strong relationship with internal and external customers · Team player · Ables to negotiate and influence · Problem solver – 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 · Ables to manage and coach a team For 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 in Belgium 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.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!