Head of Quality Site Commercial Manufacturing
il y a 2 semaines
Salary:
Highly Competitive
Job type:
PermanentDiscipline:
Good Manufacturing Practice (GMP)
Location:
Belgium- Brussels, Belgium
- Posting date: 27 Mar 2024
Reference:
59456
Purpose:
The Global Head of Quality for Sites commercial manufacturing is responsible for overseeing all aspects of quality assurance.
The role will lead and operate quality linking business and manufacturing processes to customer needs and expectations as well as regulatory compliance.
This role will have responsibility for overseeing the quality systems and product quality characteristics at internal commercial manufacturing facilities with technologies ranging from Bio and Pharma drug substance, sterile injectable solutions, medical devices, and solid oral dosage finished drug products.
The Global Head of Quality for sites commercial manufacturing is overseen the Quality organizations across all manufacturing sites within UCB.
This position is also a member of the Global Quality Leadership team of UCB and reports to the Global Head of Quality.
This position oversees 130 associates and has responsibility for leading the strategic quality plan in collaboration with the Technical Operations Leadership Team, as well as development and execution of the Quality and Compliance business goals for UCB's commercial manufacturing sites.
The Global Head of Quality for sites commercial manufacturing, provides strategic decision making, leadership, planning and prioritization including agility in effective and efficient use of resources and organizational structure across the network to meet business and quality objectives.
Results are achieved through a culture of regulatory compliance, high quality, continuous improvement, efficiency (e.g. quality resolution and release time) and customer focus.This role will also provide QA oversight for Global Engineering, Manufacturing Excellence, and Global Analytical Operations, driving continuous improvement and fostering a culture of quality within the organization.
Key Responsibilities:
- Member of the QA Leadership Team (LT), setting strategic directions for internal commercial manufacturing Quality activities.
- Member of the internal manufacturing leadership "at par"
- Demonstrates broad knowledge of worldwide guidance, practices and regulations governing UCB's commercial supply activities and manufacturing sites.
- Lead and manage each Site QA head and their teams at various manufacturing sites, ensuring alignment with global QA strategies and objectives
- Provide QA oversight for Global Engineering, Manufacturing Excellence, MSAT and Global Analytical Operations departments ensuring compliance with regulatory requirements and UCB quality standards.
- Promotes collaborative partnerships with crossfunctional teams to educate, assess and prevent potential regulatory or safety risks.
- Represents QA in committees and meetings, maintains contact with government agencies, and articulates goals and expectations.
- Responsible for staff and talent management, including performance management.
- Ensures strategic alignment with UCB values and policies, effective risk management, and excellent managerial and interpersonal skills.
2. MAJOR ACCOUNTABILITIES
- Leads the rollout and ongoing compliance of UCB's global quality and compliance systems.
- Provides leadership and resource management support for quality oversight on UCB manufacturing sites globally.
- Promote and guide a quality culture within manufacturing sites and global engineering, MSAT, manufacturing excellence departments.
- Ensures a permanent right to operate by maintaining sites in an inspection and audit readiness status.
- Establish measures that monitor key elements related to Quality.
- Determine key strategic plan elements and organize goals and objectives into longrange plans.
- Analyze and report product and process quality trends against internal and external guidelines.
- Deploy uniform and globally operating Quality systems into the manufacturing environment, based upon corporate strategies, policy, procedure, and the quality management processes.
- Chairs highimpact inspection readiness steering committee (as needed) and ensures appropriate and timely communication to senior management.
- Leads the review and support the implementation of Quality Improvement/remediation plans for Manufacturing Sites.
- Ensure timely and effective communication of qualityrelated issues to relevant stakeholders and support local site complete resolution.
- Chairs the Site Commercial Quality Operations Leadership Team, fostering a proactive approach to compliance.
- Fosters a culture of knowledge and good practices sharing among internal and external QA to drive continuous improvement and innovation.
- Has accountability for the QA budget and costing structure, creating a performance culture with a sharp focus on the customer.
Delegate:
The incumbent will be the delegate of the Head of Quality Assurance of UCB.
**3. E
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