Johnson & Johnson Careers

BioResearch Quality & Compliance Pharmacovigilance Manager

Warsaw, Poland
R&D


Job Description

Requisition ID: 1805690917W

The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
 
BioResearch Quality & Compliance Pharmacovigilance Manager
Location: Warsaw, Poland
Full time permanent contract
 
Role Overview:
The BioResearch Quality & Compliance Pharmacovigilance Manager independently leads the planning, conduct and reporting of BioResearch Q&C routine and non-routine Good Clinical Pharmacovigilance (PV) audits/assessments and supports inspections of the J&J Consumer sector worldwide, including J&J Operating Companies (including Consumer for pharmacovigilance), partners and service providers. Serves as subject matter expert in Pharmacovigilance and/or one or more compliance disciplines or areas (e.g. GLP, GCP, computerized systems, non-regulated area) and acts as a contact for internal and/or external stakeholders.  
 
You will have the following areas of responsibility:
  • Independently leads the planning, conduct and reporting/follow-up of BioResearch Q&C routine and non-routine PV audits/assessments/inspections of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.  
  • Non-routine audits include Due Diligence, for cause audits, cross-functional, system/service provider audits as defined by the scope. 
  • Manages complex or business critical audits/issues in a supporting or leading role for the region.
  • Conducts Peer review of audit reports.
  • Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
  • Participates in regulatory inspections in a leadership role (e.g. host, backroom lead).  Identifies training needs and facilitates training for Consumer auditees. 
  • Independently advises and coaches other auditors.
  • Completes training requirements in a timely manner to ensure inspection readiness at all times.  Leads initiatives and actively participates in key projects.
  • Interacts with key stakeholders and is able to influence and effectively drive projects to completion.
  • Actively shares business area and regulatory knowledge/expertise for the PV/Safety community within Consumer.
  • May act as a primary contact for internal and/or external stakeholders.  Independently provides consultation and advice to Business Partners and the core business sector on quality and compliance processes/procedures, specifically as it relates to PV and safety related activities. 
  • Interprets and applies regulations/policies to unique and/or complex issues, when required. 
  • Provides strategic input during the development of processes/procedures

Qualifications
Qualifications and experience of the successful candidate:
  • A minimum of a Bachelor’s Degree is required. 
  • A minimum of 5 years in an R&D, Post Marketing Safety, PV and/or quality and compliance area required. 
  • Thorough knowledge of the drug development process and regulatory framework globally of PV/Safety required. 
  • Expertise in GVP regulations required.  Knowledge of procedural and records management requirements in a regulated industry required. 
  • Prior pharmaceutical, consumer personal products and quality/compliance related experience preferred.  Knowledge of auditing techniques required. 
  • Must have excellent communication skills and be fluent in written and spoken English.
  • Must be a team player, organized and detail oriented, and possess sound problem solving and good negotiating skills.
  • Must be proficient in Microsoft Office applications and possess a Quality mindset.
 
This position requires overnight travel, nationally and internationally, up to 30%.
 
We Offer:
  • Unique opportunity to become part of a global consumer healthcare market leader
  • Versatile and fulfilling role in a dynamic and international corporation
  • Work in a supportive and highly professional team
  • Further opportunities for professional development and career growth
  • Motivating financial remuneration & numerous employee benefits
     
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.

Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
R&D
Requisition ID
1805690917W