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[Quality] Director, Regulatory Compliance (Japan) - 2406182696W

Description

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company,

touching the lives of nearly a billion people every day. Our Family of Companies throughout the world

compete in pharmaceutical, and medical devices and diagnostics markets and have the skills and

resources to tackle the world's most pressing health issues. We are currently recruiting for Director,

J&J Regulatory Compliance (Japan) to be located in Japan.

DESCRIPTION

The Director, J&J Regulatory Compliance (Japan), reports directly to the Senior Director, J&J

Regulatory Compliance (Asia Pacific).

Director, J&J Regulatory Compliance (Japan) will be a member of the J&J Regulatory Compliance

(Asia Pacific) team and a member of the Sector Regulatory Compliance team within the JJRC

organization that he/she supports. The Director, J&J Regulatory Compliance will work closely with the

Business/Franchise and Supply Chain compliance leads. This position is responsible for key

compliance oversight and execution of key compliance programs to drive proactive and sustained

compliance to enable strong coordination of compliance activities between businesses/franchises,

operating companies, and manufacturing sites (internal and external) with primary focus in Japan.

The Director, J&J Regulatory Compliance (Japan) will also direct team(s) of compliance professionals

to execute tactical compliance activities at the internal manufacturing sites (Fuji and Xian) in the

region.

RESPONSIBILITIES

Serve as an expert regulatory compliance advisor and Subject Matter Expert on key strategic and

critical compliance issues or activities, including due diligence, integrations, regulatory agency

interactions, regulatory inspections, inspection readiness (including mock inspections),

recovery/remediation, Quality System and Compliance Analysis, special investigations, critical

new product strategies, and independent oversight of Internal Audit programs.

Support successful product realization and advice businesses/franchises and Supply Chain on

compliance strategies. Understands compliance risk profile, proactively identify, communicate and

prioritize compliance risks. Partner with stakeholders to escalate critical risks to the appropriate

levels of management and support the mitigation of compliance risk.

Serve as a Subject Matter Expert to support proactive or reactive responses to issues including

on-site support during regulatory agency inspections as well as review responses to regulatory

agency inspections as necessary.

Proactively identify and prioritize compliance risks at their assigned sites or across the supply

chain in general.

Lead a team(s) of compliance professionals to provide compliance oversight and execute

compliance programs to ensure compliance with all voluntary, regulatory, and statutory standards

and requirements.

Establish organizational talent strategy to include goals and objectives, performance and

development and career and succession planning.

Support J&J Regulatory Compliance (JJRC) as required in providing independent review and

classification of all Regulatory Health Authority inspections and observations.

Support JJRC, as required, in providing independent classification of severity of all Field Actions.

Ensure implementation of the escalation processes as aligned with Enterprise escalation

processes. Assure operating units are fully complying with escalation processes.

Conduct Independent Audit follow-up and recall follow-up assessments, as necessary.

Assure the execution of the JJRC common practices for Independent Audit, Escalation (within

JJRC), Recovery, Post Acquisition Assessment, Internal Audit Oversight and Inspection Support

& Readiness.

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 routinely monitoring and verifying of implementation activities.

Partner with Regional Regulatory Affairs, Regional Commercial Quality, Regulatory Affairs

colleagues, Government Affairs colleagues, and Enterprise Regulatory Outreach (ERO) council to

develop and share understanding of emerging issues and trends.

Represents J&J Regulatory Compliance (Asia Pacific) in applicable Q&C & JJRC LT Forums and

Councils.

Provide regulatory compliance support to ad hoc committees and projects as necessary.

Qualifications

REQUIREMENTS

Bachelor’s degree in science or related field is required.

Graduate degree/studies in science, engineering, business, organizational management, or

equivalent experience preferred.

Significant experience in managing all aspects of Quality and Regulatory Compliance in a

regulated healthcare environment, specifically in Japan, is required.

Experience in managing all aspects of Quality and Regulatory Compliance in an international /

global regulated healthcare environment is preferred.

Minimum of 15 years of experience in Quality Assurance, Regulatory Affairs and/or Compliance,

in Japan is required.

Minimum 15 years of experience performing GxP, GMP audits / support of pharmaceutical,

medical devices or consumer health care manufacturing sites in Japan is required.

Experience working in the Pharmaceutical or Medical Device Industry/Sector is required.

Experience working with regulatory agencies, preferably with those in Japan, is required.

Detailed knowledge of Japan Pharmaceutical and Medical Device regulatory requirements is

required. Additional working knowledge of other Asia Pacific regulatory requirements is an

advantage.

Demonstrated track record of achieving successful compliance outcomes, remediating

compliance issues and supporting regulatory agency inspections is required.

Experience interpreting regulatory requirements in the light of current guidance and regulatory

body field activity.

Experience managing multiple projects, prioritizing and adapting to business needs and

understanding of business requirements.

Ability to build partnership, manage complexity and mediate issues is required

Must have strong collaboration and influence management skills to partner effectively with

Enterprise functions and across Operating Units, and ability to build consensus and impact

outcomes without always having line authority.

Proven track record of demonstrating collaboration across the organization and at all levels, and

leading direct or indirect teams to deliver results is required.

Strong analytical and critical thinking skills and experience implementing risk-based oversight

programs is required.

Ability to balance technical understanding of products and processes with compliance perspective

and business acumen is required.

Excellent communication and executive presentation skills is required.

Must be able to communicate effectively in both Japanese and English languages.

Others:

Must have credibility with external regulatory agencies, specifically Japan regulatory agencies.

Must be able to quickly build credibility within the Quality and Compliance community, executive

management, external regulators, and industry.

Accountability, with a strong desire to commit, be held accountable and be rewarded for

delivering results. Recognizes and builds support for change. Engages in constructive conflict.

Financial, moral, personal integrity and the values that inspire trust in the organization.

Must be able to generate enthusiasm for best-in-class performance through the clear personal

passion to be the best in these areas.

Ability to stand firm while being open for new approaches.

Ability to discern critical issues amidst broad operating unit complexity and to engage and

achieve executive management support for proactive and reactive measures.

LOCATION

This position will be based in Japan and may require up to 40% travel both domestically or

internationally.

Primary Location Asia Pacific-Japan-Tokyo-To-Chiyoda

Organization Janssen Pharmaceutical K.K. (7195)

Job Function Enterprise Compliance

Req ID: 2406182696W