Vendor Quality Lead

Il y a 3 mois

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **Clinical Manufacturing Quality** department we are looking for a talented profile to fill the position of **Vendor Quality Lead** - **Braine l’Alleud, Belgium**

**About the role**

As Vendor Quality Lead, you will ensure that manufacturing operations for External Manufacturing Vendors and Partners meet regulatory and product quality requirements. This role supports New Chemical Entities, New Biological Entities, and New Gene Therapy Products.

You will oversee development operational activities, including batch record review and release, and actively participate in selecting, evaluating, and approving third-party contractors for development activities. This includes conducting audits and managing ongoing QA relationships to ensure compliance with UCB and regulatory standards. You will collaborate with other departments to resolve compliance and quality issues, drive continuous QA improvement processes, and ensure that the Quality Management System supports CMC Development effectively. Additionally, you will provide guidance to Development scientists on interpreting national and international GMP regulations and guidelines.

**You will work with**

As Vendor Quality Lead, you will collaborate closely with various departments and external partners. You will work with External Manufacturing Vendors and Partners to oversee manufacturing operations and ensure compliance with regulatory and product quality standards. Additionally, you will engage with third-party contractors for development activities, conducting audits and managing QA relationships. Internally, you will partner with departments such as Development, Compliance, and Quality Assurance to identify and resolve compliance and quality issues.

**What you will do**
- Be the central QA point of contact for the organization for investigations / deviations / out-of-specifications / audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow assessment.
- Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors and track the vendor’s performance
- Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement
- Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
- Quality Complaints: be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, record of quality complaints into the UCB Complaint System and provision of responses to the complainant are professionally coordinated and managed.
- Cover the entire product life cycle from early phase to commercial launch of the product, including Technology Transfer/Knowledge transfer, to phase out for the assigned DEV vendors
- Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
- Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of UCB development activities and ensure compliance with regulatory and corporate requirements.
- Lead the Vendor Management System to ensure appropriate qualification (initial and maintenance) of Development Vendors
- Ensure adequate documentation processes and systems are available and followed
- Proactively support the activities of CMC and Development QA for relevant manufacturing quality systems (deviation close out / Change management/ complaints / quality improvement)

**Interested? For this position you’ll need the following education, experience and skills**
- Bachelor's or Master's degree required, auditor certification and preferred sciences certifications/registrations (e.g., medical, pharmacy, nursing, public health) are a plus.
- Fluent in English (oral and written); additional languages are a plus.
- A minimum of 5 years of to 10 years of extensive experience in a regulated pharmaceutical environment.
- QP certification will be considered an advantage
- A complete understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
- QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences
- Experience sterile parenteral and or Biological prod

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