Sr. Director, Quality, Regulatory Compliance Medical Devices APAC

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Job Description


·       This role is responsible to establish and lead Johnson & Johnson One MD APAC’s overall quality management framework and quality system, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities, clear alignment to company strategic objectives and J&J corporate quality policies.

·       The scope of this role includes the Depuy Synthes, Ethicon and Cardiovascular Specialties and Solutions franchises in the APAC organization across all umbrella and direct business units. Responsibilities may be altered at the discretion of the OneMD VP Business Quality and as determined by changing APAC business needs.

·       Success in this role will ensure that the Quality community operates as a change agent across the business, standard operating procedures and processes are in place across all businesses and countries and that all business projects are completed with appropriate project plans.



Oversee Management of Quality System

·       Lead the J&J MD APAC Business Quality Organization, ensuring a proactive approach to   quality assurance and quality systems.


·       Provide end-to-end quality and compliance leadership and serve as voice of quality on Regional Commercial leadership team.


·       Ensure safe and compliant processes for storage, distribution and marketing of medical devices and medicinal products in MD APAC.  Partner with Deliver Operations and Quality partners to ensure appropriate roles and responsibilities are developed between LOC and Deliver organizations for distribution and logistics activities.


·       Embed quality management system into the relevant business processes and ensure compliance to local Health Authority requirements, J&J Quality Policy and relevant Enterprise and Sector Quality Standards


·       Implement applicable regulatory requirements (GMP, GDP, MD, Local Health Authorities etc.) into SOP’s and work instructions and ensure effective flow down in the organization through qualified and educated associates and a comprehensive training system


·       Partner and collaborate with both Enterprise and Regional Regulatory Affairs organizations to ensure timely gathering and assessment of new/revised regulatory requirements (regional+local)  while sustaining country specific commercial activities. In concert with Regulatory Affairs obtain and maintain needed registrations and licenses for the distribution of medical devices and medicinal products


·       Ensure engagement of commercial and cross-functional partners through the Management Review and Escalation process to guarantee appropriate resources and support are provided to execute required quality system elements in a robust manner.


·       Ensure audit readiness for successful Health Authority and other regulatory body audits/inspections and associated interactions and communication ~ (85-100 audits/year)


·       Put in place systems and processes (and collaborate with Franchises, Supply Chain and other functions like Medical and Legal) for effective management of customer complaints, field actions and vigilance reporting as part of the overall Post-Market Surveillance system (PMS)/Pharmacovigilance System (PV).


·       Develop appropriate strategic and process performance measures/targets.


·       Manage the overall corrective action and preventive action (CAPA) and risk management processes.


·       Work closely with the MD Business Quality, Regulatory Compliance and Quality Systems teams to leverage knowledge to transfer already well-documented and proven quality tools and programs.


·       Establish and maintain global and local relationships with partnering organizations and regulatory bodies.


·       Lead cross-functional teams and provide subject matter expertise to other functions.


·       Engage and lead Cross Segment initiatives in countries to improve efficiencies in the operation of the QMS


·       In accordance to purchasing controls local regulations and JNJ standards establish oversight and effective monitoring process for suppliers ~ 270 and distributors ~ 200.


·       Oversee the management of APAC Standard Operating Procedures, ensuring simplicity, standardization and education across the countries.


·       Operate as a key business partner for quality and process improvement, understand business requirements and execute quality and continuous improvement programs to drive organization capability building.


·       Ensure troubleshooting and solutions to quality issues through statistical analysis and quality, engineering, and process excellence tools.  Ensures Regional Leadership is aware of issues, metrics, and initiatives, and engaged as needed.


Strategy & Planning

·       Develop a common vision and strategy of/for Quality and Process Improvement in alignment with regional commercial strategy for the MD business including Go to Market strategies and portfolio demands.


·       Ensure an Enterprise mindset within the APAC MD Quality organization by championing partnering and sharing with Cross-Sector and Deliver Quality colleagues


·       Foster a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of appropriate tools to drive business results


·       Conduct business assessments and identify/prioritize strategic improvement and deployment projects


·       Embed QMS management principles in the organization and business processes, creating cross- functional process improvement teams who effectively complete improvement projects central to these efforts.


·       Engage all company employees in these initiatives, through interactive project coaching/consulting and change management strategies


·       Implement APAC Talent Strategies to grow regional quality capabilities, provide development opportunities for key talent, and drive a global mindset within the region. Work with Cross-Sector, Quality Operations, and Deliver Quality partners to ensure a cohesive APAC Quality Talent Strategy.


·       Develop appropriate strategic and process performance measures/targets.


New Business Development & Relationship Management

·       Develop Business Quality and Regional Quality talent pool and ensure capabilities are in place to become self- sufficient in the necessary aspects of Quality.


·       Partner with the Quality Community, Business Leaders, PE Leaders, Process Owners & Project Teams


·       Provide oversight to the Quality activities required to execute Divestitures and Acquisitions



·       Bachelors or Master's degree in Business, Biosciences or Engineering or equivalent field coupled with extensive and relevant business experience in Quality leadership roles.




·       Capable of managing complexity across One MD business to consistently deliver customer expectations while meeting health authorities requirements.

·       Process Excellence experience across diversified business areas or equivalent quality standards programs.

·       Relevant experience in the healthcare or pharmaceutical industry is essential along with supply chain, project management and change management experience.

·       Strong leadership capabilities and a proven track record of leading or coaching teams to achieve significant quality and process improvements.

·       Examples of having lead teams through change, preferably across different geographies.

·       Strong people development capabilities and examples of promotions and successful talent import/export

·       Proactive, have excellent influencing and interpersonal skills with the ability to identify, implement and manage multiple priorities.

Primary Location
Johnson & Johnson Pte. Ltd. (8435)
Job Function
Requisition ID