Sr Manager QA Pharmacovigilance

☞ Incyte

View: 204

Update day: 24-04-2024

Location: Morges Vaud VD

Category: Quality Assurance / Quality Control

Industry: Biotechnology Hospital & Health Care Pharmaceuticals Biotechnology Research Hospitals Health Care Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Summary

The Sr Manager QA PhV will play lead role in the oversight and assessment of GVP activities to ensure robust systems and processes for global Pharmacovigilance activities.

This position is responsible for providing Pharmacovigilance (PhV) audit support for QA management and oversight from QA aspect of global PhV activities of various teams within lncyte (Global PV departments, Clinical Development teams and others relevant departments/function with pharmacovigilance activities) to the Head of lncyte Global QA Clinical and PhV.

This job will include the execution and management of lncyte QA PhV/GCP audits and the provision of PhV /GCP guidance and advice across relevant Post-marketing and Clinical Development areas.

Duties And Responsabilities

QA Pharmacovigilance
  • Lead the establishment, maintenance and execution of the GPvP audit program (Processes, affiliates, vendors, business partners and all others relevant structures/functions identified).
  • Lead the maintenance of the PhV Quality Management System including QA support for PhV supplier qualification, risk management, change control, deviations, review of SOPs with ensuring continuous process improvement
  • Establish robust collaboration with PhV Leaders, including EU-QPPV.
  • Reviewing key pharmacovigilance documents, e.g. PSMF, reports, and regulatory submissions.
  • Assist in preparing, coordinating and hosting Inspections/Partner audits in collaboration with the PhV function.
  • Support the development of the PhV training program in collaboration with PhV group.
  • Coordinate responses and corrective/preventative actions from deviations, audits and regulatory inspection findings.
QA PhV And Clinical Global
  • Stay abreast of Pharmacovigilance and Safety regulations, EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
  • Escalate to Global QA Clinical/PhV Management of internal and external serious non-compliance/deviations in a timely manner.
  • Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned.
  • Assist with the management of QA consultants performing audits on behalf of lncyte Corporation.
  • Foster a relationship of trust and effective communication with functional stakeholder
  • Be knowledgeable with assigned lncyte compounds and protocols, and be able to understand advanced operational, scientific and/or medical problematic
Requirements
  • Minimum Bachelor’s degree in a science or healthcare related discipline, or similarly conferred degree from a University
  • 3 - 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a PV QA role with a minimum of 2 years’ lead auditor experience performing GVP compliance audits of vendors and business partners.
  • Ability to travel a minimum of 30%.
  • Prior GVP I GCP inspection experience preferred.
  • Thorough knowledge in cGCP and cGVP and global regulatory requirements;
  • Experience in managing Audit contractors
  • Strong Interpersonal skills, including organizational sense, rational and autonomy
  • Strong verbal and written communication skills with well-structured communication and presentation ability;
  • English fluency written and spoken (the company language);
  • Knowledge of other languages such as French is an asset;
  • Results focused which may require negotiating skills and diplomacy,
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here .

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Deadline: 08-06-2024

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