Associate Director Commercial Affiliate QA (GMP/GDP and Pharmacovigilance)

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 Associate Director Commercial Affiliate QA (GMP/GDP and Pharmacovigilance) to join our team.

Job Responsibilites:

The Associate Director Commercial Affiliate QA (GMP/GDP and Pharmacovigilance) is a strategic role to achieve enhanced Quality and Regulatory (GMP/GDP and GVP) Compliance within specific assigned Idorsia affiliate(s) by maintaining and improving the standardized QMS across affiliates aligned with Headquarter (HQ) QA requirements and ensuring adherence to GMP, GDP and GVP requirements for the Idorsia products within the Supply Chain.

• Maintain and drive compliance of the affiliate Quality Management System (QMS) against the company’s Quality Policies, industry standards and local GMP/GDP and GVP related regulatory requirements.
• Ensure local PV related vendors/external partners in the affiliate are qualified (Approved Supplier List) and are appropriately monitored/audited against relevant company and local standards.
• Lead / support in collaboration with HQ QA external audits and inspections and report and track these and any other relevant field action activity into the relevant quality systems. Ensure that the affiliate QMS is in constant state of readiness for planned and ad hoc audits or inspections. This activity should be performed as appropriate in collaboration with the Local Responsible Person, the EU QPPV/National QPPV/Affiliate Safety Manager and any other relevant stakeholder.
• Based on local requirements, conduct as appropriate GxP related self-inspections and PV audits that are applicable to the affiliate activities, respectively perform internal audits/self-inspections of other affiliates.
• Manage affiliate documentation and training records within Idorsia QMS, in collaboration with HQ QA, other affiliate QA colleagues and affiliate. Review and approve local and multi-site (GxP related) standard documentation and develop local/multi-site Quality related procedures as appropriate, in accordance with HQ QA principles and processes and EU / national regulation.
• Ensure the provision of appropriate quality related training for regulated activities in the affiliate and monitor training compliance.
• Ensure appropriate and timely management of non-conformances related to relevant GxP (GMP/GDP/GVP): deviations, change controls, internal and external CAPAs, Quality Events.
• Monitor QMS 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. 
• 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/GVP). Keep affiliate Management and HQ QA informed about significant changes and maintain an updated record of applicable country specific laws, regulations, requirements and regulatory procedures related to quality (GMP/GDP/GVP). Support the Affiliate Safety Manager 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 in 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

• Manage excellent relationship with commercial business partners in the affiliate and act as trusted and well-known partner 

Candidate’s Requirements  

• Graduate Degree in Pharmacy, or other scientific or health related fields (BSc at minimum); additional experience in Quality Assurance/Compliance and Auditing
• Fluent in English and German both written and spoken required, additional European languages are a plus
• Experience: at least 10 years of experience in pharmaceutical industry thereof at least 5 years in GDP QA / PV QA field for commercial products, GMP experience is a plus
• Experience in regulatory inspection management, interactions with health authorities
• 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 in a matrix organization
• 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. 
• Able to identify and propose management of quality and compliance risks considering business needs
• Proficient in the use of Microsoft Office applications
• Experience as a registered Qualified Person in the European Union is an advantage

What Idorsia offers

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

Work Location: Allschwil – Basel Area
Country: Switzerland
Business Area: Technical Operations - Quality Assurance
Schedule: Fulltime
Job Type: Permanent
Job ID: 4529
 

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.