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Qualified Auditor as Head of Quality Management - GMP, GXP (m/f)

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We are a leading independent development organization of biosimilar medicinal products for the global market, in which it has taken on a pioneering role.

Our team consists of highly experienced experts with decades-long experience in the development of novel biopharmaceuticals, biosimilars and complex generic molecules, having already developed and out licensed biopharmaceutical product portfolios incl. the first European biosimilars.

Building on its unique base of expertise, our company develops high-quality biosimilars that fulfil the stringent requirements of drug regulatory authorities in highly regulated markets, such as Europe and the United States. With its first biosimilar drug candidate already licensed out, we currently have two products in the development pipeline, along with further biosimilar drug development candidates in the planning phase. We develop biosimilars up to marketing authorization and performs clinical and commercial manufacturing in collaboration with large contract manufacturing organizations (CMOs).
 

For the support of our team in Martinsried we are looking for a
 
Head of Quality Management (GMP / GXP)  (m/f)
 
This Senior Management level position in a semi virtual organized pharmaceutical development company will supervise the quality management system and coordinate the day-to-day business for GXP compliance. This position will contribute extensively to cross-functional product development programs and supply chain set-up.
This role requires a strong scientific and organizational approach and profound QA expertise in the pharmaceutical environment, the ability to establish mutual respect, trust, and close collaborations with partners, and to communicate and connect with all levels of the organization.

The Head of Quality Management will report to the Director Regulatory Affairs and Quality Management of the company.

Responsibilities:
  • Plan, manage and provide quality oversight for all GXP areas.
  • Expand and maintain a quality management system for the company including all departments ranging from CMC & Quality Operations, preclinical development, clinical development to meet GMP, GCP and GLP requirements.
  • Manage quality agreements, Site Master File, SOP & CAPA system, internal and external audits, inspections as well as EMA/FDA readiness programs.
  • Analyse relevant directives, laws, regulations, pharmacopoeias, guidelines and comparable documents and adapting the new standards within the company
  • Manage change control for all relevant procedures and establish approval workflows.
  • Ensure GXP compliance (internal and external) of documentation, e.g. preclinical and clinical plan/reports, manufacturing documentation and archiving thereof.
  • Plan, conduct and/or coordinate internal and external audits to ensure GXP compliance of our contract manufacturing and pre-/clinical contract research organizations
  • Manage communication and interactions with local and international authorities in the GXP area.
  • Organize and conduct internal GXP trainings and promote internal GXP understanding and needs.
  • Attend project meetings as required and provide guidance with regard to GXP requirements and ensure clear communication of GXP needs.
  • Plan, organise and execute international Quality Management meetings
  • Provide input to the development of program strategy, budgets, timelines, and development plans.
Qualifications and skills:
  • Proven track record with a minimum of 5-10 years of experience in QM/QA area and GMP compliance ideally in a small to medium-sized company. Additional experience and training in GCP and/or GLP quality systems preferred.
  • Profound knowledge of the relevant national and international legal and regulatory requirements and guidelines.
  • Trained and qualified auditor with extensive experience in site manufacturing audits of biopharmaceutical drug substance and parenteral drug product CMOs for clinical and commercial scale manufacturing. Additional experience in GCP and/or GLP audits would be of benefit.
  • Expert technical experience in relevant fields, e.g. establishment of quality assurance agreements, site master files, interaction with local authorities and audits / due diligences of large pharma companies (EU, US).
  • Proven knowledge of the biopharmaceutical drug development process including drug regulatory standards, QA/GXP related early and late stage activities and supply chain management.
  • Experience in pre-approval inspections for biopharmaceutical or biosimilar registrations is a plus, but not required.
  • Fluent in written and spoken German and English.
Are you interested?
Please send your application to jv63663@jobvector.com.

We are looking forward to receiving your application.
Please specify your salary requirements and earliest possible starting date.

Kontaktdaten


Art des Bewerbungszugangs
Please send your application to jv63663@jobvector.com.
Kontakt für Bewerbungen
We are looking forward to receiving your application.
Please specify your salary requirements and earliest possible starting date.

Details der Stellenanzeige


Arbeitszeit
Vollzeit
Vertragslaufzeit
Festanstellung
Stellentyp
Bereichs- & Abteilungsleitung
Berufserfahrung
Berufserfahrung vorausgesetzt
Region
Deutschland (Bayern)
Arbeitsort
82152 Martinsried
Fachgebiet
Pharma, Biologie & Life Sciences, Chemie, Biotechnologie, Chemieingenieurwesen & Verfahrenstechnik
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