Senior Commercial (PV/GxP) QA Manager Italy

Location: 

Milan, MI, IT

 

 

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 Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in the Basel Area (Allschwil) 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 1000 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for a Senior Commercial (PV/GxP) QA Manager to join our affiliate in Milan (Italy).

 

Job Responsibilities


Senior Commercial (PV/GxP) QA manager is a strategic role to achieve enhanced Quality and Regulatory (PV, GMP/GDP) Compliance within EU Idorsia affiliates by developing and implementing a standardized QMS across EU affiliates aligned with HQ QA requirement. This person will ultimately cover for an EU affiliate cluster of several countries. 

 

  • Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company’s Quality Policies, industry standard and local PV, GMP/GDP related regulatory requirements
  • Manage Affiliate documentation and training record 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 (PV, GMP/GDP): change controls, internal and external CAPAs, Quality Events, deviations.
  • 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. 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.
  • 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.
  • Support the Local responsible Person for Monitoring and evaluating 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


Key Working Relationships

 

To perform the different tasks, collaborate effectively with various internal and external partners, such as the local Health Authorities, the Local responsible Person, the ASM, Regulatory Affairs, Medical Affairs, Medical Information, Marketing, Market Access, other EU affiliate Cluster, HQ QA and any other relevant functions.

 

Candidate’s Requirements

 

  • Graduate Degree in Pharmacy, or other scientific or health related fields (BSc at minimum); additional knowledge in Quality Assurance/Compliance and Auditing
  • Fluent written and spoken English and Italian are required
  • Experience : 8 years of experience in pharmaceutical industry in QA or PV field including 5 years in the area of PV quality assurance and experience in GMP/GDP 
  • Prior PV auditing experience
  • Experience in regulatory inspections 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
  • Comprehensive knowledge of PV regulations. Basic knowledge of GMP/GDP requirements 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 propose balanced management of quality and compliance risks with business needs.
  • Ability to travel at least 15% of the time
  • Proficient in the use of Microsoft Office applications
     

 

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 benefits

 

Work Location: Milan
Country: Italy
Business Area: Quality Assurance
Schedule: Fulltime 
Job Type: Permanent 
Job Id : 2930

 

 

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 will be informed in greater detail in due course.

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, please note that 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.