Job type: Full-time

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Position Title: External Manufacturing Regulatory Compliance Head

Supervisor Title: Vice President Pharmaceutical Regulatory Compliance

Department Name: Pharmaceutical Regulatory Compliance

Physical Location of Role: Raritan - NJ, Titusville - PA, Horsham - PA, Spring House - PA, Schaffhausen - Switzerland, or Beerse - Belgium

Position Summary

The Head of External Manufacturing Regulatory Compliance serves as a key member of the Pharmaceutical Regulatory Compliance Leadership Team. They provide leadership for the development, deployment and maintenance of strategic regulatory compliance programs for the External Pharmaceutical Supply Chain (e.g External Manufactures, Suppliers, etc). This individual leads a team of compliance professionals to provide expert cGMP/GXP compliance oversight for Janssen activities regulated by FDA and international health authorities.

This individual partners closely with Janssen Supply Chain (JSC) Quality leadership to assure compliance programs are implemented and maintained. They serve as a key compliance advisor and Subject Matter Expert (SME) for regulatory compliance. They collaborate with business partners to mitigate compliance risk and support sites in preparing for, managing, and responding to health authority inspections. They partner with sites and management to identify and resolve quality and compliance issues.

Major Duties & Responsibilities

Serves as an expert regulatory compliance advisor and Subject Matter Expert on key strategic and critical compliance issues across the external Janssen Supply Chain. Serves as a regulatory compliance authority for the business on critical compliance activities such as: risk management, due diligence, pre-approval inspections, licensing and acquisition, regulatory agency interactions, regulatory inspections, remediation, decommissioning, divestiture, and critical new product strategies.

Proactively identify and prioritize risks and provide balanced management of those risks with business needs. Provide innovative solutions to cross-functional compliance issues, assuring that the solution falls within appropriate regulatory guidance. Partner with stakeholders to escalate critical risks to the appropriate levels of management.

Lead a team(s) of regulatory compliance professionals to provide compliance oversight and execute compliance programs (e.g. inspection readiness, Ext Mfg follow-ups, etc) to ensure compliance with all voluntary, regulatory and statutory standards.

Partner with operating units to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations. Support implementation plans for regulatory requirement changes including routine monitoring and verification of implementation activities

Provides visibility to Compliance metrics, new/changing Health Authority regulations and/or changing expectations and results of Health Authority inspections in External supply chain.

Assure compliance programs are implemented and maintained at external supply chain sites. Interface with leadership teams across JSC to drive effectiveness and efficiency in compliance programs.

Manage a team of Compliance personnel in order to accomplish compliance goals. Including:
  • Develop the team, ensuring there is a breadth of quality/compliance expertise in all product platforms and product types within JSC and provide compliance advice and coverage for the external supply chain.
  • Develop and achieve short term targets and longer-term strategies. Defines and implements departmental strategies and ensures departmental initiatives maximize customer value.
  • Establish organizational talent strategy to include goals and objectives, performance and development and career and succession planning. Ensure organizational depth to meet present and future business needs.
  • Accountable for performance management, personnel development and timely completion of 5 Conversations.
  • Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices

Other Duties

Actively participates in industry forums to drive alignment on regulatory expectations and emerging trends, develop approaches to new technologies and foster open and transparent channels with health authorities.

Qualifications

Required Minimum Education: Bachelor’s Degree in Biology, Chemistry, Pharmacy or related field

Required Years of Related Experience: 12+ years of experience in Quality Assurance, Regulatory Affairs and/or Regulatory Compliance

Required Knowledge, Skills And Abilities
  • Significant experience in managing all aspects of Quality and Regulatory Compliance in a global, regulated healthcare environment.
  • Experience working in the Pharmaceutical, Medical Device, or Consumer regulated healthcare environment.
  • Intimate knowledge of pharmaceutical manufacturing and testing processes. Thorough technical knowledge of cGMPs and International regulatory requirements.
  • Experience working with, or for, the United States Food and Drug Administration (FDA) and other foreign regulatory agencies. Hands-on experience interacting with regulatory authorities and demonstrated ability to develop and maintain strong relationships with Regulatory agencies is required.
  • Demonstrated track record of achieving successful compliance outcomes, remediating compliance issues and supporting and/or managing regulatory agency inspections. Demonstrated track record of leading direct and indirect teams to delivers results.
  • At least 10 years of experience performing GMP audits and/or providing compliance expertise to pharmaceutical manufacturing sites.
  • Experience interpreting regulatory requirements in the context of current guidance and international regulatory body field activity. Must be able to formulate and influence policy and provide input to decisions across sites.
  • Strong technical, business and relational skills in a broad range of compliance areas. Ability to balance technical understanding of products and processes with compliance perspective and business acumen.
  • Ability to build partnerships, manage complexity and mediate issues, and to build consensus and impact outcomes without always having line authority; able to negotiate trade off decisions across the organization.
  • Ability to effectively communicate requirements and regulatory issues to all levels of the organization. Effective verbal and written communication skills. Strong executive presentation skills.
  • A thorough understanding of business requirements and the ability to adapt to changing business.
  • Strong decision-making and analytical skills. Experience implementing risk-based oversight programs across multiple businesses
  • 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

Travel on the Job: Yes, domestic and international.

Percentage Traveled: 15-40%

Preferred Related Industry Experience
  • QA/RA certification preferred
  • Cross-segment experience preferred
  • Previous experience working inside a regulatory agency (e.g. FDA, MHRA, etc)

Preferred Knowledge, Skills And Abilities
  • Sterile / aseptic processing
  • External manufacturing

Primary Location

United States-New Jersey-Raritan-1000 US HIghway 202

Other Locations

Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House

Organization

JANSSEN SUPPLY GROUP, LLC (6046)

Job Function

Quality

Requisition ID

2105979184W

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Deadline: 04-05-2024

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