Quality Director Manufacturing, Europe

Quality Director Manufacturing, Europe

Reckitt

Schiphol, Netherlands

About the role

A member of the Europe Quality Leadership Team (EUQLT), the Quality Director Manufacturing, Europe proactively drives quality compliance performance and has overarching strategic quality leadership responsibility for the Europe Core Reckitt Quality team in the region.

Supply Region:

• Business Partnering with the Regional & Site Leaders;
• Providing strategic quality leadership input at a regional level;
• For Product Distribution, provides strategic quality leadership to the Supply Team on requirements for all product categories.

Internal Factories:

• Ensures compliance of all operations to internal and external requirements;
• Maintains necessary quality certifications and licences;
• Executive responsibility for the release for sale decisions;
• Establish and maintain a QMS and across the supply chain, liaising as required with EUANZ Commercial Quality;
• Drive improvements in compliance and efficiency.

Scope:

• Chartres, Weinheim, Mira, Nowy Dwor, Tuzla factories.

Your responsibilities

Accountablities:

• Overarching leadership responsibility for Quality compliance of all factories, within the current scope of the role;
• QMS Maintenance and Improvement across region;
• Leadership and development of the Quality Team within the region;
• Passing all Internal and external quality audits;
• Driving improvements to key KPIs;
• Innovation in Quality processes/controls/Identifying processes where human errors are possible, build a case for action and drive the creation of Tech enabled fail-safe solution cross-functionally;
• Design, build and implement a Culture of Quality program across the region.

Key Challenges:

• Balancing the pace with ensuring no compliance issues;
• Managing complexity; multiple factories, diverse product portfolio;
• Ensuring consistency of standards across our manufacturing sites;
• Assessing and keeping up to date with the requirements of multiple regulatory authorities, including FDA, EMEA etc.

The experience we're looking for

Skills & Experience required:

• At least 10 years of experience working in a quality, operations and or compliance function in a Healthcare, Pharmaceutical, or Medical Device related industry;
• Quality Leadership experience in a strategic role;
• Experience in developing and maintaining a robust QMS in a Healthcare, Medical Device or Hygiene related industry;
• Good understanding of regulatory, GMP and GDP requirements relevant to a regulated products as required e.g., EU GMP, EU GDP, WHO, PIC/S, CFR 21 Part 210/211; the role of the local competent authority in registering sites;
• Auditing skills, with appropriate qualifications in auditing an advantage;
• Strong communication skills;
• Proven influencing skills;
• Diplomatic and tactful in challenging situations;
• Highly motivated and able to self-manage time and workload;
• Organised and able to deliver concise written or oral summaries to senior management.

Technical/professional qualifications required:

• Bachelor’s or advanced degree in the sciences or supply chain related degree;
• Experience of interacting with regulatory inspections;
• Good understanding of GMP, GDP and quality management systems;
• Thorough knowledge of the regulatory requirements, rules and guidance covering the distribution of products and medical devices;
• English speaking (essential).

The skills for success:

Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing.

Apply Now