Head of Commercial and Batch Release
Head of Commercial and Batch Release
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Job Description
PURPOSE OF THE FUNCTION:
Clear Leadership and Vision: Lead and drive the Commercial and Batch Disposition team to align with and achieve argenxs vision and mission.
Robust Compliance: Maintain a sustainable robust and compliant batch release and Marketing Authorization Holder (MAH) (MIA) system.
Foster Strong Partnerships: Excel at building and maintaining strong collaborative relationships with internal and external stakeholders to effectively deliver the product portfolio expansion commercial strategy.
Promote CrossFunctional Collaboration: Establish a seamless partnership with the Commercial counterparts in TechOps ensuring strong alignment between Product Quality and crossfunctional teams
ROLES AND RESPONSIBILITIES:
Lead motivate and guide the Commercial and Batch Disposition teams to achieve excellence in all aspects of their work.
Drive and establish a clear quality and business objectives ensuring timely monitoring of batch release performance and progress against defined goals.
Lead the PQ Commercial and batch disposition team in the global expansion efforts and the successful launch of new products fostering innovation and operational readiness and also partner with the commercial manufacturing team in TechOps in the global expansion efforts and the successful launch of new products.
Drive the commercial and batch disposition team in maintaining the Marketing Authorization Holder (MAH) and (MIA )compliance and readiness for regulatory inspections.
Lead and drive initiatives to continuously improve the Quality Management System (QMS) and operational practices by benchmarking industry standards evaluating stakeholder requirements and defining performance metrics.
Lead the design and of a comprehensive compliance framework for batch release processes ensuring seamless adherence to regulatory standards across both commercial and clinical products.
Lead the design and of digital transformation of batch release processes to enhance efficiency data integrity and compliance.
Drive the creation and implementation of Standard Operating Procedures as an author reviewer and approver.
SKILLS AND COMPETENCIES:
Collaborative leadership and team player
Ability to effectively lead motivate and coach the team on quality and key business priorities
Excellent organizational and interpersonal skills
Excellent stakeholder management skills
Strong analytical and problem solving skills
Solid scientific writing and reporting skills
Extensive knowledge and experience in GMP area within a biopharmaceutical company
Extensive knowledge of Health authority regulations such as the FDA EU and PMDA and ICH Guidelines and strong business knowledge of the major markets US EU Japan etc)
EDUCATION EXPERIENCE AND QUALIFICATIONS:
Educated to degree level (preferably PHD or Masters) in a relevant commercial pharmacy or engineering discipline
5 10 years of experience in GMP and supply with indepth knowledge of commercial GMP and GDP processes.
Extensive experience in successfully managing Health Authority inspections
Certification as a Qualified Person is a desirable.
Required Experience:
Director
Employment Type
Full-Time
