Director, Qualified Person

About Idorsia Pharmaceuticals Ltd
Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.

We are looking for a talented and passionate Director, Qualified Person to join our team.

Job Responsibilites:

• Ensure that each GMP batch of medicinal product is manufactured and analysed in accordance with the GMP guidelines and European directives 2001/83/EC as amended, the Quality and Technical Agreements and the Marketing Authorisation

• Certify and release (resp. reject) medicinal product batches for the markets in the EU/EEA, US and for export to other markets in accordance with Section 19 AMG, Section 16 AMWHV, Annex 16 and Annex 13 EU GMP Guidelines, respectively Detailed Commission guideline of 8 December 2017, and entry in a batch register

• Verify that each batch of medicinal product is distributed under conditions that meet the GDP guidelines according to chapter 2.2 of the European GDP-guidelines

• Evaluate deviations and changes in view of GMP and regulatory compliance

• Participate in the evaluation of pharmaceutical-technical complaints and product returns. Decision on quarantine status and product recall (EU), if applicable. Participation in the coordination and processing of product recalls (EU)

• Where required, review/assess data provided by internal departments and/or external partners in view of quality oversight for the related products and provide QP support

• Help ensure activities at CMOs and deliverables are in compliance with FDA, EMA and other global regulations and guidances, ICH guidelines, company’s policies, SOPs and industry best practices

• Take decision to initiate recall in alignment with the competent authorities

• Participate in external audits and self-inspections and qualification of contract manufacturers and distributors, assessment of audit reports

• Take responsibility for quality communication, reviewing and compiling technical and quality agreements with assigned partners

• Support in regulatory and other inspections and audits

• Improve and keep up-to-date relevant documents and SOPs in the Quality System

• Review and approve Annual Product Quality Reviews

• Assess customs and pharmaceutical requirements for import and export of starting materials, finished medicinal products and investigational medicinal products

• Oversee importation of medicinal products into the warehouse in Germany

• Participate in inspections by competent authorities and follow-up in consultation with management

• Manage the retention sample storage

• Maintain the GMP/GDP compliance of the site

• Other duties as assigned

Candidate’s Requirements  

• Pharmacist experienced as Qualified Person (QP), at least 10 years of relevant experience in an industrial pharmaceutical setting, thereof at least 5 years of experience as a QP (small molecules, solid and parenteral dosage forms, commercial and investigational medicinal products)

• Expertise according to § 15 AMG, considering § 138 sub paragraph 2, § 141 sub paragraph 3, § 142 sub paragraph 1, § 144 sub paragraph 4 AMG, proof of the required reliability (certificate of good conduct)

• Excellent knowledge of the European and US GMP guidelines and quality directives, German national legislation (AMG, AMWHV) and other applicable regulatory requirements

• Fluent in German and English (written and spoken)

• In depth knowledge and experience with quality systems, deviations, change control, corrective action and preventive action system, quality risk management, outsourcing of manufacturing activities and key tools for managing quality performance

• Strong sense of responsibility, accurate and pragmatic style of working

• Ability to find solutions to problems and set priorities

• Ability to hold one's ground under pressure

• Excellent communication and sound decision-making skills

• Team player with collaborative style of working, resilient and flexible

• Strong interpersonal skills

• Must be able to handle multiple tasks simultaneously in a fast-paced environment

• Excellent MS Office knowledge, ERP and eQMS knowledge (e. g. SAP and Veeva)

• A plus is experience with GDP and GVP QA in a commercial environment

Work Location: Allschwil – Basel Area
Country: Switzerland
Business Area: Technical Operations - Quality Assurance
Schedule: Fulltime
Job Type: Permanent
Job ID: 4570
 

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

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 would be informed in greater detail in due course.

Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants  must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. 

Please note 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, 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.