Director, Head of Quality Assurance (GMP/GDP)
Director, Head of Quality Assurance (GMP/GDP)
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 Europes leading biopharmaceutical company, 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 600 highly qualified
specialists dedicated to realizing our ambitious targets.
We are looking for a Head of Quality Assurance (GMP/GDP) to join our company
Job Responsibilities
- Responsible for the leadership and overall supervision of the GMP/GDP QA Team (approx. 20 personnel, including 3
direct reports)
- Provide clear leadership to the team across the scope of GMP, GDP and compliance topics, and facilitate a high level
team spirit and cross functional interaction
- Coach and develop staff by providing an environment that encourages ongoing personal and professional development
- Maintain oversight and manage all required GMP/GDP QA activities which support release of IMP and commercial
products, including approval of master process documentation, batch record review, resolution of quality related
defects/investigations and assessment of change controls
- Collaborate with the EU QP/RP to interact with Health Authorities on GMP/GDP compliance topics and to manage the
planning, conduct, reporting and follow-up of regulatory agency inspections
- By implementation of robust QA processes, ensure that appropriate procedures are in place for the development,
manufacture and release of IMP/medicinal products in accordance with Good Manufacturing Practice, current manufacturing
licences and marketing authorization, as applied at Idorsia HQ (CMU & ADQC facilities), as well as at Idorsia affiliate
sites and at external CMOs
- Actively support the organization in matters of regulatory requirements, technology advancement and training
expectations
- Notify management of potential quality and regulatory issues, including communication on batch rejection and/or
recall situations
- Ensure the qualification status of the GxP environment
- Generate and approve GMP/GDP regulatory relevant documents
- Ensure implementation of robust GMP/GDP audit qualification activities at all Idorsia sites, and where necessary,
participate in the conduct of internal/external audits
- Provide technical and compliance guidance on deviation management, technical/product quality defect investigations,
CAPAs, and change management procedures
- Provide guidance on the resolution of testing issues, discrepancies and Out of Specifications (OOS) investigations
and Corrective and Preventive Actions (CAPA)
- Monitor efficiency of the pharmaceutical quality system (PQS), establish relevant KPIs to monitor efficiency, define
and implement improvements of the PQS when required
- Independently deal with complex and difficult situations, work under pressure, prioritize tasks with focus on
providing a customer-oriented service
Candidates Requirements
- Preferably Pharmacist, or advanced university degree in Pharmaceutical Sciences or Chemistry (minimum level -
Masters Degree)
- QA professional with at least 10 years experience encompassing all areas of pharmaceutical development
(manufacturing and analytics), including at least 5 years experience in Quality Assurance activities
- Previous experience in a management capacity. Proven ability to take decisions, with sound risk assessment and stand
for these.
- Previous appointment as "EU Qualified Person" and "Responsible Person" (Fachtechnisch verantwortliche Person)
advantageous
- Comprehensive knowledge of current pharmaceutical legislation and international GMP/GDP regulatory requirements,
coupled with the ability to accurately interpret applicable requirements and implement robust procedures at all Idorsia
sites
- Extensive knowledge on product development processes (IMPs) and commercial manufacturing operations
- Excellent knowledge on processes for the development, manufacturing, control and testing of drug substances and drug
products for all pharmaceutical dosage forms, including aseptic processing
- Experience in medical device/combination products would be advantageous
- Proven experience related to Health/Monitoring Authority inspections
- Strong interpersonal skills and the ability to facilitate and develop working relationships with stakeholders built
on respect, trust and collaboration
- Ability to communicate clearly and professionally both verbally and in writing
- Fluent in English language and good knowledge in German language would be an asset
What Idorsia offers
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution oriented enviroment 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
Country: Switzerland
Business Area: Pharmaceutical Development
Schedule: Fulltime
Job Type: Permanent
Job ID: 1431
If you are interested, please click on apply now.
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.
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.
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 Europes leading biopharmaceutical company, 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 600 highly qualified
specialists dedicated to realizing our ambitious targets.
We are looking for a Head of Quality Assurance (GMP/GDP) to join our company
Job Responsibilities
- Responsible for the leadership and overall supervision of the GMP/GDP QA Team (approx. 20 personnel, including 3
direct reports)
- Provide clear leadership to the team across the scope of GMP, GDP and compliance topics, and facilitate a high level
team spirit and cross functional interaction
- Coach and develop staff by providing an environment that encourages ongoing personal and professional development
- Maintain oversight and manage all required GMP/GDP QA activities which support release of IMP and commercial
products, including approval of master process documentation, batch record review, resolution of quality related
defects/investigations and assessment of change controls
- Collaborate with the EU QP/RP to interact with Health Authorities on GMP/GDP compliance topics and to manage the
planning, conduct, reporting and follow-up of regulatory agency inspections
- By implementation of robust QA processes, ensure that appropriate procedures are in place for the development,
manufacture and release of IMP/medicinal products in accordance with Good Manufacturing Practice, current manufacturing
licences and marketing authorization, as applied at Idorsia HQ (CMU & ADQC facilities), as well as at Idorsia affiliate
sites and at external CMOs
- Actively support the organization in matters of regulatory requirements, technology advancement and training
expectations
- Notify management of potential quality and regulatory issues, including communication on batch rejection and/or
recall situations
- Ensure the qualification status of the GxP environment
- Generate and approve GMP/GDP regulatory relevant documents
- Ensure implementation of robust GMP/GDP audit qualification activities at all Idorsia sites, and where necessary,
participate in the conduct of internal/external audits
- Provide technical and compliance guidance on deviation management, technical/product quality defect investigations,
CAPAs, and change management procedures
- Provide guidance on the resolution of testing issues, discrepancies and Out of Specifications (OOS) investigations
and Corrective and Preventive Actions (CAPA)
- Monitor efficiency of the pharmaceutical quality system (PQS), establish relevant KPIs to monitor efficiency, define
and implement improvements of the PQS when required
- Independently deal with complex and difficult situations, work under pressure, prioritize tasks with focus on
providing a customer-oriented service
Candidates Requirements
- Preferably Pharmacist, or advanced university degree in Pharmaceutical Sciences or Chemistry (minimum level -
Masters Degree)
- QA professional with at least 10 years experience encompassing all areas of pharmaceutical development
(manufacturing and analytics), including at least 5 years experience in Quality Assurance activities
- Previous experience in a management capacity. Proven ability to take decisions, with sound risk assessment and stand
for these.
- Previous appointment as "EU Qualified Person" and "Responsible Person" (Fachtechnisch verantwortliche Person)
advantageous
- Comprehensive knowledge of current pharmaceutical legislation and international GMP/GDP regulatory requirements,
coupled with the ability to accurately interpret applicable requirements and implement robust procedures at all Idorsia
sites
- Extensive knowledge on product development processes (IMPs) and commercial manufacturing operations
- Excellent knowledge on processes for the development, manufacturing, control and testing of drug substances and drug
products for all pharmaceutical dosage forms, including aseptic processing
- Experience in medical device/combination products would be advantageous
- Proven experience related to Health/Monitoring Authority inspections
- Strong interpersonal skills and the ability to facilitate and develop working relationships with stakeholders built
on respect, trust and collaboration
- Ability to communicate clearly and professionally both verbally and in writing
- Fluent in English language and good knowledge in German language would be an asset
What Idorsia offers
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution oriented enviroment 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
Country: Switzerland
Business Area: Pharmaceutical Development
Schedule: Fulltime
Job Type: Permanent
Job ID: 1431
If you are interested, please click on apply now.
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.
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.
Allschwil / Basel area - Allschwil
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