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Johnson & Johnson Loopbaan

Senior Manager, Regulatory Compliance

Leiden, Nederland
Regulatory Compliance


Vacatureomschrijving

Requisition ID: 1905724026W

POSITION SUMMARY:

The Sr. Manager of Global Compliance manages activities related to the deployment and maintenance of the Janssen Supply Chain (JSC) centralized Global Compliance programs including: internal auditing, advisory notices,

field actions, inspection readiness, regulatory outreach, escalation, and compliance metrics and reporting. Develops and maintains Global Compliance procedures for compliance related topics and provides input

concerning JSC Standard and SOP development and implementation. Leads Global Compliance audits of internal sites / systems, performs Mock Pre-Approval Inspections (PAIs) and other inspection readiness assessments.

Supports Global Compliance oversight by managing activities related to regulatory compliance at designated JSC Sites including: resolves planned and unplanned issues by recommending and monitoring corrective measures,

provides support to site(s) in preparation of and during regulatory agency visits, assists with development of responses to regulatory observations. Provides benchmark data on current issues and industry compliance related topics. Remains up to date on current industry regulations, guidelines and standards and communicates to management and the organization on health authority focused issues.

 

 

ESSENTIAL FUNCTIONS:

  • Develops audit plans, schedules and leads audits in support of the Global Compliance internal audit function.
  • Facilitates assessments including focused reviews: Pre-PAI Audits, Due Diligence Audits and Gap Analyses to support business needs and assess compliance risk for the organization.
  • Determine and communicate JSC sites’ state of readiness for health authority inspections.
  • Support inspection readiness programs for JSC sites. Provide on-site coaching in support of audits and regulatory agency inspections, including front and back room support, personnel coaching and review, and response to regulatory agency observations.
  • Manage, maintain and/or deploy Global Compliance programs and processes.
  • Track, trend and report compliance metrics.
  • Provides tactical, regulatory and business knowledge to drive compliance improvement projects.
  • Provide input to development and implementation of Global Standards and procedures.
  • Provides benchmark data on current issues and industry compliance related topics. Remains up to date on current industry regulations, guidelines and standards and communicates to management and the organization on health authority -focused issues.
  • Acts as a central compliance source to JSC sites and site compliance managers.
  • Interfaces with management & leadership teams across JSC sites to achieve harmonization & standardization of practices & policies in order to improve core process reliability and efficiency.
  • Acts as a resource to JSC employees to keep up to date with compliance environments
  • Acts as a liaison with J&J Q&C WW regarding specific compliance related initiatives.
  • Review and assist with major investigations throughout the company.
  • Participates on company wide projects, new product launches or lean projects for compliance.
  • Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures.
  • Position requires approximately 25-30% travel.

Kwalificaties

EDUCATION and/or EXPERIENCE:

  • BA or BS in Biology, Chemistry or related field is required.
  • Technical knowledge of cGMPs, international regulatory requirements and knowledge of pharmaceutical manufacturing and testing.
  • Minimum of 8 years of experience in Quality Assurance, Regulatory Affairs and/or Compliance is required.
  • Previous auditing experience and understanding of compliance programs such as escalation, advisory notices, field actions and inspection readiness is required.
  • Experience in communication of requirements and regulatory issues.
  • Experience interpreting regulatory requirements in the light of current guidance and international regulatory body field activity.
  • Experience managing multiple projects, prioritizing and adapting to business needs and understanding of business requirements.
  • Manage relationships internally and externally and build cross functional/departmental effectiveness.

Other: Detail and goal oriented, focused on team work and the customer, prioritize and adapt to business needs, effective verbal and written communication skills, conflict and change management skills, influencing and

negotiating, strong decision-making and analytical skills. Mature skills in the following Global Leadership areas: Integrity and Credo Based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual

Curiosity; Sense of Urgency; Results and Performance Driven; Collaboration and Teaming; Prudent Risk Taking;

and Self Awareness and Adaptability.


Primaire locatie
Nederland-Zuid Holland-Leiden-
Organisatie
Janssen Vaccines & Prevention BV (8852)
Functie
Regulatory Compliance
Requisition ID
1905724026W