Director, IMP Quality, Europe Head

BeiGene

Basel, Switzerland

General Description:

The position will report to Distribution & Regional Quality, Europe Head. The Director IMP Quality Europe will provide GMP/GDP expertise and supervise the clinical trials supplies within the EU and Switzerland and ensure the correct handling of the IMP (Investigational Medicinal Product). The incumbent will ensure that clinical products are manufactured, packed, labelled, distributed, and controlled in accordance with regulatory expectations and applicable quality standards.

Essential Functions of the job:

Ensure that the requirements of all relevant national and international guidelines and internal policies/SOPs are met, in particular consider the requirements of Clinical Trial Regulation and EU GMP/GDP-Guideline;
Point of contact for IMPs and other clinical supplies related quality activities;
Collaborate with External Supply Quality in case of vendor interaction;
Ensure that quality processes are sustainable and meet Health Authorities expectations;
Manage and guide an IMP expert team;
Support functions and SMEs to maintain and improve the inspection readiness process;
Batch disposition of finished products manufactured by toll manufacturers on behalf of BeiGene;
Primary interface to EU Qualified Persons for clinical trial;
Lead quality investigations to ensure thoroughly investigation with appropriate corrective actions;
Provide support for process performance qualification activities including document review and approval;
Advise and support Quality Agreement content, implementation, and updates;
Monitor performance metrics and drive continuous improvements;
Assess and revise, as needed, SOPs and identify opportunities to streamline systems and processes;
Actively contribute to establish and review Global Quality Standards to ensure compliance with local law requirements;
Support regulatory filings, as needed;
As a plus: Qualifies as EU Qualified Person according to §15(1) German Drug Law.

Supervisory Responsibilities:

Lead the IMP Quality Europe team, provide coaching, and support development plans.

Experience:

Master’s degree in science or combination of education and equivalent work experience;
10 - 15 years pharmaceutical or biotechnology industry experience;
Extensive GMP experience in a quality and manufacturing function;
Worked in technical development and clinical environment, commercial experience is an asset.

Core Knowledge and Skill Requirements:

Ability to build up a team and effectively manage staff;
In-depth knowledge of GMPs, especially focus on phase-appropriate GMPs;
In-depth knowledge of Quality principles, concepts, industry practices and standards;
Working Knowledge and experience with 21CFR210, 21CFR211, ICHQ7 as well as international regulations;
Excellent verbal, written and interpersonal communication skills;
Ability to work independently with scientific/technical personnel;
Experience with regulatory compliance inspections;
Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems;
Must possess strong presentation skills to speak effectively before groups; ability to respond;
Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail;
Strong Project Management Skill Set;
Qualification as EU Qualified Person according to §15(1) German Drug Law (Arzneimittelgesetz, AMG) is a plus.

Computer Skills:

PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio);
Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAP; IWRS; Audit Utopia; Empower; LIMS, etc.;
UL ComplianceWire; UL LearnShare.