Senior Director, Head of QA Commercial Affiliates
Location: Basel, CH
The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.
Headquartered in Switzerland – a biotech-hub of Europe – Idorsia is a high-potential biopharmaceutical company, specialized in the discovery, development, and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.
We are looking for a Senior Director, Head of QA Commercial Affiliates to join our team!
Job Responsibilities
* Develop a scalable, proactive commercial Quality organization anticipating future needs in Europe, US, and other countries, including oversight of commercial GMP / GDP / PV activities.
* Develop and lead the commercial QA affiliate representatives at Idorsia affiliates.
* Obtain and maintain the required licenses in different countries to support launches and subsequent commercial activities worldwide.
* Set goals to support Quality and Corporate needs.
* Support and represent Idorsia Quality during inspections and discussions with health authorities and senior leaders at Contract Organizations in Europe.
* Manage performance and development of direct reports and consultants to ensure achievement of organizational and departmental goals.
* Negotiate and manage quality agreements.
* Lead teams in executing quality targets and goals.
* Develop and implement the Idorsia QMS at affiliates.
* Help ensure the quality of products produced/maintained at CMOs.
* Participate in external and internal audits as relevant.
* Perform audits and self-inspections.
* Act as QP or deputy QP when needed.
* Hire and develop top talent.
* Continuously improve the Quality system.
* Drive changes and lean activities to foster a quality culture and improve site performance.
* Lead, coach, and mentor employees in QA to build high-performance teams.
* Manage regulatory inspections and health authority requests to obtain and maintain licenses.
* Interface with senior management on quality and compliance issues.
* Coordinate between RPs and QPs to align processes and discuss issues.
* Ensure activities comply with Swissmedic, FDA, EMA, and other global regulations, ICH guidelines, policies, SOPs, and industry best practices.
* Preferred experience includes:
* Experience as Qualified Person (QP) in the EEA.
* Experience as Responsible Person (RP, Fachtechnisch verantwortliche Person, FvP) in Switzerland.
* Experience as Responsible Person (GDP-RP, Verantwortliche Person für den Großhandel).
Candidate’s Requirements
* A Master’s degree or equivalent in a scientific discipline (Pharmacy, Biology, Chemistry, Biochemistry); advanced degrees are a plus.
* At least 10 years of experience leading in the pharmaceutical industry.
* At least 5 years of experience leading in Quality Assurance.
* Ability to influence and maintain a quality culture.
* Flexibility and adaptability in managing change.
* Knowledge of global cGMPs and GDPs, with a focus on Swiss and EU laws.
* Experience managing CMOs is preferred.
* Strong interpersonal and team skills.
* Excellent verbal and written communication skills.
* Analytical and systematic thinking abilities.
* Fosters accountability, diversity, and open communication.
* Ability to manage budgets and resources, and lead a department.
* Proven leadership skills in motivating and leading teams.
* Registered as Swiss Responsible Person and Qualified Person per Annex 16.
* Legal eligibility to register as QP and GDP-RP.
* Experience as lead auditor.
What Idorsia offers
* Home-office option.
* Collaborative, solution-oriented environment.
* Innovative, multicultural culture.
* Competitive salary and social benefits.
Work Location: Allschwil – Basel Area
Country: Switzerland
Business Area: Global Quality Assurance
Schedule: Full-time
Job Type: Permanent
Job ID: 4608
At Idorsia, we value diversity, authenticity, and inclusion. We are committed to equal opportunity employment. All qualified applicants will receive consideration without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or disability.
Please note that employment is subject to a pre-employment background check. Idorsia works with a list of preferred recruitment partners; submissions through unauthorized channels are considered the property of Idorsia and are not eligible for fees.
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