[Quality] Senior ManagerDirector Commercial Quality [IM]
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
People LeaderAll Job Posting Locations:
Chiyoda Tokyo JapanJob Description:
Overall Purpose of the Role
The Senior Manager / Director of Commercial Quality serves as the Japan Quality Leader responsible for ensuring that postmarketing GxP activities are executed in accordance with Japan Good Quality Practice (GQP) J&J global quality policies and MAH (Marketing Authorization Holder) requirements.
The role safeguards business continuity product quality regulatory compliance and patient safety.
When the candidates qualification meets the requirement the position also fulfills the full legal responsibilities of Marketing Supervisor General for pharmaceuticals (class I II) and regenerative products as defined under the PMD Act ensuring market quality oversight and regulatory compliance.
Key Responsibilities:
1) Quality Management System (QMS) Governance
- Establish maintain and continually improve a compliant GQPaligned Quality Management System covering all postmarketing activities.
- Ensure that internal and external manufacturing sites supplying Japan operate in compliance with GMP and GQP requirements.
- Ensure local processes are aligned with global and regional policies standards and governance requirements.
- Lead QMS performance management including metrics management reviews and continuous improvement.
2) GxP Compliance and Regulatory Oversight
- Oversee local implementation of regulatory and corporate quality requirements across all GxP functions.
- Ensure timely monitoring and implementation of evolving regulatory expectations.
- Maintain readiness for internal audits and regulatory inspections.
- Represent Japan in regional and global quality initiatives.
Market Supervision Responsibilities (Marketing Supervisor General PMD Act)
As the legally accountable Marketing Supervisor General the role has endtoend responsibility for market quality surveillance and postmarketing compliance.
1) Market Quality Surveillance Key Responsibilities
- Monitor quality and safety issues arising in the Japanese market and take timely and appropriate actions in collaboration with the QA Manager (Hinseki) and Safety Manager (Anseki)
- Oversee complaint handling postmarketing quality investigations and regulatory reporting requirements.
- Lead qualityrelated decisions for recalls product holds and field safety actions.
- Ensure proper oversight of distribution and storage quality for Japan commercial operations.
2) MAH and Regulatory Accountability
- Ensure compliance with all legal obligations under the PMD Act related to product quality safety and documentation.
- Serve as the primary contact for regulatory bodies on postmarketing quality matters.
- Ensure that MAH-required records and documentation are accurate complete and audit-ready.
3) Governance and Escalation
- Lead market risk assessments and escalate significant market quality issues to senior leadership.
- Ensure transparent communication and effective decision-making for issues impacting patient safety product integrity or market supply.
4) Leadership and Cross-Functional Responsibilities
- Directly supervise and develop the Quality Assurance Manager (Hinseki).
- Ensure adequate resourcing capability and training across all GxP teams.
- Provide strong crossfunctional alignment with Supply Chain Deliver Medical Regulatory Pharmacovigilance/ Safety and Commercial teams.
- Develop robust talent succession plan of Soseki role in the organization.
- Represent quality perspectives in business strategy product planning and operations.
Required Qualifications
- Licensed Pharmacist (mandatory requirement for Marketing Supervisor General under PMD Act.
- Minimum 10 years of Quality Management experience in pharmaceutical or biotechnology industry.
- Minimum 10 years of people leadership experience.
- Deep knowledge of GQP GVP and GMP requirements.
- Strong communication skills and capability to influence senior leadership.
- Experience representing quality in executive forums and strategic discussions.
Additional Notes
- This role is critical for regulatory compliance patient safety and business continuity.
- Responsibilities may be adjusted based on evolving regulatory or business requirements.
Required Skills:
Preferred Skills:
Compliance Management Continuous Improvement Corrective and Preventive Action (CAPA) Developing Others Fact-Based Decision Making Give Feedback Inclusive Leadership ISO 9001 Leadership Performance Measurement Quality Control (QC) Quality Management Systems (QMS) Quality Processes Quality Standards Standard Operating Procedure (SOP) Succession PlanningRequired Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
