C&Q Lead Job Description
At QbD Group, we offer knowledge and tailored solutions in development, clinical, regulatory & compliance, production, and distribution for companies active in Pharma, ATMP, and Medical Devices/IVD. We are always looking for the next QbD'er in Qualification & Validation.
Both employees and freelancers are welcome to apply for this opportunity.
What do we expect from you as a C&Q Lead?
As a Commissioning & Qualification (C&Q) Lead, you will take the lead in two major initiatives at a Small Molecule site:
* A site-wide C&Q Remediation Project following current assessments and gap analysis
* A capacity expansion project involving a new Spray and Post Dryer unit
Your responsibilities will include:
* Leading qualification & commissioning efforts in both remediation and expansion projects
* Defining C&Q strategy and plans aligned with GMP and Risk-Based C&Q principles
* Ensuring timely execution of documentation, FATs, commissioning, and qualification activities (IQ/OQ/PQ)
* Collaborating with internal and client stakeholders to ensure project alignment
* Supporting audits and regulatory inspections as C&Q subject matter expert
* Coaching validation professionals involved in the project lifecycle
Job Requirements
Bachelor's/Master's Degree
* In Life Sciences, Engineering, or related field
Work Experience
* Minimum 10 years of experience in Commissioning & Qualification within life sciences
Skills and Qualifications
* Solid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodology
* Familiarity with GMP, FDA, EMA regulations
* Fluent in English; Dutch is a plus
* Proven leadership and stakeholder management skills
* Analytical, solution-oriented, and able to manage complex project dynamics