Job description
Job Title: Equipment Qualification Squad Lead (Consultant)
Location: Geel, Belgium (On-site presence required, minimum 80%)
Contract Type: Full-Time, Consultant
About Amaris Consulting:
Amaris Consulting is an independent technology and management consulting firm providing guidance and solutions to businesses worldwide. We are seeking an experienced Equipment Qualification Squad Lead to join our team as a consultant, working on-site at one of our key clients in the pharmaceutical manufacturing sector.
Position Overview:
As an Equipment Qualification Squad Lead, you will co-lead the initiative to align all existing equipment qualifications at our client’s site with current industry best practices, focusing on risk-based approaches. You will partner with the local process owner and collaborate closely with project and quality teams to ensure compliance, quality, and sustainable change.
Key Responsibilities:
* Provide expert guidance on equipment qualification best practices and science-based, risk-based approaches.
* Oversee multiple projects and manage resources (including contractors), applying robust project management methodologies to ensure successful delivery.
* Ensure project outputs and deliverables meet internal and external regulatory requirements, working closely with the Quality Assurance lead for alignment.
* Drive change management initiatives to support the sustainable adoption of best practices across the organization.
* Mentor and coach the Local Process Owner (LPO) to enhance their knowledge and skills in line with industry standards.
Profile Requirements:
Required Qualifications:
* Extensive experience in equipment qualification within a pharmaceutical manufacturing environment.
* Preferably experienced in API environments, including batch chemical reactors, spray dryers, (post) dryers, and centrifuges.
* In-depth knowledge of FDA and EMA requirements for equipment qualification, with hands-on experience in risk-based approaches and qualification documentation.
* Strong project management, organizational, planning, and coordination skills.
* Excellent interpersonal and communication abilities.
* Proven experience leading teams in complex and dynamic environments.
* Skills in coaching, human change management, and training.
* Ability to navigate organizational dynamics, interact at various levels, and influence without direct authority.
* Fluency in English is required; Dutch is preferred.
What We Offer:
1. The opportunity to work on a high-impact project with a leading client in the pharmaceutical industry.
2. A dynamic and supportive consulting environment.
3. Professional growth and development opportunities within Amaris Consulting.