Job Number: 17596

External Description:

Job Title: Associate Director, Quality Engineering
Location: Yorkshire/Humber 
Contract: Permanent, Full Time
Work Hours: 37.5

 

Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for an Associate Director, Quality Engineering on behalf of a global CDMO organization.

 

Role Purpose:

In this role you will be responsible for managing the quality oversight during the Engineering, Commissioning & Qualification phases of GMP-relevant systems (facilities, equipment, utilities, and computerized systems) within the scope of a capital investment project. The role requires managing a team of QA Qualification Experts, ensuring that activities are carried out in accordance with the Company standards, expectations of cGMP regulations, as well as industry best practices.

 

Key Accountabilities:

• Manage quality and compliance-related responsibilities during the various project phases from basic/detailed design through Commissioning and Qualification (C&Q) to the handover to Operations;
• Ensure that Direct Impact Systems (DIS) within the project scope, such as facilities, equipment, utilities, and computerized systems, are qualified for their intended use according to the Company’s  standards and regulatory expectations. 
• Review and approve C&Q documentation of DIS, such as URS, system classification, FRA, DQ, FAT/SAT, IQ, OQ, PQ, QSR.
• Undertake Quality Risk Management activities to proactively minimize potential quality issues and ensure regulatory compliance.
• Support the transition of project phases from the planning and C&Q  execution to the handover to Operations and Inspection Readiness.
• Collaborate with the Project Leadership Team to ensure alignment of the project execution strategy and to achieve quality and compliance goals.
• Train, supervise, and coach the QA Engineering Team.

 

Key Requirements:

• Proven leadership skills and results driven oriented. 
• Relevant experience in Quality Engineering, CQV, Quality Compliance, Engineering or Operations
• GMP knowledge mandatory
• Small molecule, API experience a strong asset 
• Pharmaceutical experience a strong asset

Job Number: CONF0458

Community / Marketing Title: Associate Director, Quality Engineering

Location_formattedLocationLong: Hull, Yorkshire and the Humber GB