QbD Group is an international organization with a matrix structure where internal QA operates as a shared service for the various divisions and the other shared services. As an ambitious and growing company, we frequently integrate new companies into our group through our M&A strategy. QA plays a pivotal role in establishing efficient, pragmatic and compliant processes aligned over all divisions and entities. QA supports internal and vendor audits, participates in client and regulatory inspections and upholds a comprehensive Quality Management System (QMS). On top, QA acts as consultant to the organization.

We are currently seeking a motivated, hands-on and dynamic QA Manager. In this role, you will oversee and manage the effectiveness of our quality management system, ensure compliance with ISO and regulatory requirements. As an internal QA Manager, you work closely with various departments to maintain and enhance the quality of services provided.

Utilizing your exceptional interpersonal skills, you will motivate the different teams and stakeholders to assure all systems, processes and their outcomes comply with the effective regulations. You’ll report directly to the Chief Innovations Officer of the QbD Group, located in HQ Antwerp.

What do we expect from you as our QA Manager?

Quality initiatives

• Maintain and improve the company’s QMS and ensure compliance with ISO 9001, ISO 13485, and other standards when relevant.
• Develop, implement, and review QA policies and procedures to ensure alignment with industry best practices and regulatory requirements.
• Monitor the effectiveness of the QMS through regular reviews and updates

Audits

• Plan, schedule and conduct internal audits to ensure compliance with the relevant standards, guidelines and company policies. Document findings, audit reports and ensure follow up on CAPAs
• Coordinate and support incoming client, vendor/supplier audits, incl preparation, executions and followup activities
• Act as the primary point of contact for external auditors and clients during audit processes
• Complete quality questionnaires sent by (prospective) clients

QA Consultancy and advice

• Ensure the company’s processes and documentation are in compliance with applicable regulations and standards
• Lead and participate in initiatives to enhance our QMS, quality and efficiency in a pragmatic way
• Develop and deliver training programs on quality standards, audit processes etc and with this fostering a culture of quality awareness
• Prepare and present regular reports on QA activities, audit outcomes and QMS performance to senior management

Who are we looking for?

• Master’s degree in life sciences or equivalent by experience with a minimum 4yrs’ experience within quality management experience in the life science industry and good notion of QA within CRO environment
• Minimum 2yrs’ of auditing experience (ISO13485, ISO9001, cGxP guidelines, …)
• Detailed knowledge of EMA regulations, FDA regulations etc.
• Excellent analytical, problem-solving and decision making skills
• High sense of responsibility, integrity, confidentiality and accuracy
• Ability to be flexible, to adapt and work effectively within an ever-changing environment with a variety of situations and individuals
• Proficient in MS Office 365
• Excellent English communication skills

A true QbD’er can be recognized by the following qualities:

• Resilient: Your strong and positive attitude helps you overcome any challenge
• Hungry for knowledge: You are always open to learning
• No non-sense mentality: you can be straightforward in a respectful way
• Innovative: You are constantly looking for new and better solutions
• (Not too) serious: your job is serious, but you don’t take yourself too serious.

What’s in it for you?

• QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
  

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!