QA Manager - Basel, Schweiz - Idorsia Pharmaceuticals Ltd.

Beschreibung

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options.

Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,200 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated
QA Manager GMP/GDP to join our team


Job's Responsibilities

• Provide GMP/GDP quality assurance expertise during development and commercialization of Idorsia's 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
• Assist in the conduct of GMP/GDP audits at 3rd party sites
• 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
• Proactively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones
• Release of DS and DP Bulk as defined in the relevant release SOPs
• University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum, PhD or PharmD would be advantageous
• At least 3 years of experience in different positions like pharmaceutical product development/ quality control/analytical development/ chemical production or similar operational positions in the pharmaceutical industry
• At least 3 years of experience in Quality Assurance of drug substance and/or drug product
• Comprehensive knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
• Good knowledge of 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 proactively initiate and lead quality activities
• Ability to manage multiple tasks with competing priorities
• Good interpersonal and influencing skills
• Selfconfident, 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 would be advantageous

What Idorsia offers

• Exciting opportunities for development and professional growth within our dynamic organization
• A collaborative and solutionoriented environment where you can make a difference
• An innovative and open culture in a truly multicultural environment
• A competitive salary and generous benefits

Work Location:
Basel Area - Allschwil


Country:
Switzerland


Business Area:
Pharmaceutical Development - Quality Assurance GMP7GDP


Schedule:
Fulltime


J
ob Type:
Permanent


Job ID: 3986


_At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success._
**_We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees._