Senior QA Manager Sterile Manufacturing

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 will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in the Basel Area (Allschwil) 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 800 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated Senior QA Manager Sterile Manufacturing to join our team !

Job Responsibilities

Core:

• Ensure GMP compliance of the internal sterile facility, utilities, systems and equipment
• Manage, review and approve change controls, deviations and CAPAs related to the sterile pharmaceutical operations.
• Manage, review and approve of qualification & validation documents of GMP equipment (facilities and utilities)
• Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation
• Provide relevant inputs in sterile QA processes.

Secondary:

• Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP / GDP standards and for process improvement (QS document including Quality agreements with third parties)
• Administer system for e-documentation (Idorsia EDMS)
• Establish External QA Audit and internal self-inspection Frequency based on Risk Assessment, as appropriate.
• Coordinate and conduct GMP / GDP audits and self-inspections; write corresponding audit reports
• Promptly report critical self-inspection findings to the Responsible Person and management
• Coordinate, plan and manage Regulatory Agency Inspections
• Support preparation of Regulatory Agency Inspections
• Monitor changes in quality regulations and initiate required activities to keep the quality system aligned and compliant
• Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones
• Provide coaching and advise to other QA Managers in sterile manufacturing QA field when required

Candidate Requirements

• University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum, PhD or PharmD preferred
• 10 years of experience in different positions like pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry. Minimum 6-8 years in sterile manufacturing and/or QA for steriles.
• Deep knowledge and understanding of sterile manufacturing process, quality control, packaging and distribution
• Experience in quality assurance of sterile products – minimum 8 years
• Excellent knowledge of relevant GMP/GDP and international quality regulations: ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4) and in particular GMP Annex 1
• 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 compliance 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 European language, German or French advantageous

Work Location: Allschwil- Basel Area

Country: Switzerland

Business Area: Quality Assurance

Schedule:Fulltime

Job Type: Permanent

Job Code: 2630

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.