Director, Commercial Affiliate QA GMP GDP and Qualified Person

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Location: 

Basel, BS, CH

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.

Job Responsibilities

Director, Commercial Affiliate QA(GMP/GDP) and Qualified Person is a strategic role to achieve enhanced Quality and Regulatory (GMP/GDP) Compliance within EU Idorsia affiliates by developing and implementing a standardized QMS across EU affiliates aligned with HQ QA requirements and ensuring adherence to GMP and GDP requirements for the Idorsia products within the Supply Chain. Experience as a Qualified Person, preferably in Germany, and PV QA experience is a plus.
 

• Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company’s Quality Policies, industry standards and local GMP/GDP related regulatory requirements
• Manage Affiliate documentation and training records within Idorsia Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as appropriate, in accordance with HQ QA principles and processes. 
• Ensure the provision of appropriate quality related training for regulated activities in affiliates and monitor training compliance.
• Ensure appropriate and timely management of non-conformances related to relevant GxP (GMP/GDP): deviations, change controls, internal and external CAPAs, Quality Events.
• Monitor quality system performance versus local quality relevant GxP and Idorsia requirements via use of pertinent quality and compliance metrics and goals, in alignment with HQ QA guidance and principles. As needed, collaborate with HQ QA for reflecting the affiliate indicators specifics in the HQ quality performance management review.
• In charge of affiliate Quality Management Review in collaboration with Local Responsible Person for medicinal product distribution/wholesale, if applicable. Escalate as needed to HQ QA the highlights of the affiliate’s review.
• Notify and engage HQ QA and other affected stakeholders with any substantial concerns regarding product quality, safety and/or compliance, as per the escalation procedures. 
• Lead / support in collaboration with HQ QA external audit and inspection and report and track these and any other relevant field action activity into the relevant quality systems. Ensure that the affiliate quality system is in constant state of readiness for planned and ad hoc audits or inspections. This activity should be performed as appropriate in collaboration with EU QPPV/National QPPV/Affiliate Safety Manager, the Local Responsible Person and any other relevant stakeholders.
• Ensure local PV related vendors/external partners in the affiliates are qualified (Approved Supplier List) and are appropriately monitored/audited against relevant company and local standards.
• Based on local requirement, conduct as appropriate GxP related self-inspections that are applicable to the affiliate activities, respectively perform internal audits/self-inspections of other affiliates.
• In interaction with the Local responsible person and HQ QA, process Product Quality Complaints through relevant electronic systems, escalate critical product issues and support execution of (mock) recalls and other (mock) field actions in a timely manner.
• Evaluate changes and proposed changes to country specific laws and regulations related to quality (GMP/GDP). Keeping Affiliate Management and HQ QA informed about significant changes and maintaining an updated record of applicable country specific laws, regulations, requirements and regulatory procedures related to quality (GMP/GDP). Support the ASM to conduct impact assessment for new or updated PV regulations.
• Take care of lifecycle of Commercial Quality related documentation to ensure proper documents storage and archiving, in alignment and in collaboration with HQ QA following Idorsia archiving principles.
• Participate to Industry Association/Working Groups where present to anticipate, analyze current/emerging regulations/trends that impact Quality System, as appropriate.
• Use best (industry) practice to implement and support local continuous process excellence and improvement activities, and collaborate as needed with HQ QA for reflecting on the affiliate’s quality improvements opportunities
• Drive accountability for Quality and Compliance to foster a compliance and Quality driven Culture within the affiliate
• Perform batch record reviews and deviation review and approval as a Qualified Person (QP) or on behalf of the QP, and perform batch release, if qualified and accepted as such by the local competent authority

Qualifications and Experience

• Graduate Degree in Pharmacy, or other scientific or health related fields (BSc at minimum); additional knowledge in Quality Assurance/Compliance and Auditing
• Fluent in English and German both written and spoken required; intermediate knowledge of French is a plus
• Experience: at least 5 years of experience in pharmaceutical industry in QA and PV field including GDP for commercial products and GMP
• Experience in regulatory inspection management, interactions with health authorities
• Experience as a QP
• Well-organized, able to switch priorities quickly and manage multiple activities and timelines
• Excellent communication skills (orally and in writing)
• Investigation, problem solving, risk analysis & management, negotiation and influencing skills
• Ability to work independently as well as in a team environment
• Comprehensive knowledge of GMP/GDP requirements and PV regulations including product complaint and recall management
• Able to manage and resolve technical and tactical issues according to departmental/company procedures and regulations.
• Is strategic in compliance views and is able to provide coaching and guidance to project teams in developing and implementing new quality assurance procedures. Has a quality mindset.
• Able to establish collaborative partnerships with internal and external stakeholders and colleagues, and apply diplomatic skills in resolving difficult situations. 
• Identifies and proposes balanced management of quality and compliance risks with business needs.
• Proficient in the use of Microsoft Office applications

Business Area:  Quality Assurance

Start Date : ASAP

Job Type : Permanent

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.