QA Manager

Functieomschrijving

Description of the company

The purpose of our client is to discover, develop, and commercialize innovative medicines to help more patients.

Role & Responsibilities

• Provide GMP/GDP quality assurance expertise during development and commercialization of clients products
• Ensure all required quality activities are initiated and completed according to the development stage
• Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards
• For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
• Establish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
• Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls
• Notify CMC team and management of potential quality, regulatory and lead time issues
• Participate, represent and defend quality activities in CMC team meetings
• Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
• Write, review, and/or approve internal SOP’s and other GMP/GDP related documentation
• Support review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance Indicators
• Release of DS and DP Bulk as defined in the relevant release SOPs

Candidate Profile

• University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
• 3-6 years of experience in different positions like pharmaceutical product development/ quality control / analytical development / chemical production or similar operational positions in the pharmaceutical industry
• 3-6 years of experience in quality assurance of drug substance and/or drug product
• Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
• Good knowledge of (c)GMP/GDP’s
• Ability to interpret and implement Quality standards
• Ability to manage complex projects and prioritize workload according to the project importance
• Ability to pro-actively initiate and lead quality activities
• Ability to manage multiple tasks with competing priorities
• Good interpersonal and influencing skills
• Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
• Ability to communicate clearly and professionally both verbally and in writing
• Fluent in English and at least basic knowledge of an additional language, German or French advantageous