SENIOR DIRECTOR, QUALITY & COMPLIANCE-0003140504
Description
Senior Director, Quality, Regulatory Compliance
Medical Asia Pacific
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 consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
General summary
This role is responsible to establish and lead Johnson & Johnson MD&D Asia Pac'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. In addition this role oversees the management and flawless execution of NBD quality due diligence with clear alignment to company strategic objectives and J&J corporate quality policies.
The scope of this role includes the MD&D Asia Pac Marketing companies across all umbrella and direct MD&D Franchises, The scope also includeds quality oversight of regional MD&D R&D Centers and NBD activity. Responsibilities may be altered at the discretion of the MD&D CQO and as determined by changing Asia Pac business needs.
Reports To: Vice President, Strategic Business Systems, J&J Medical Asia-Pacific
Dotted to: Vice President, MD&D Market Quality
Job responsibilities include:
Manage Quality System
- Lead the J&J MD&D Asia Pac Quality Community, ensuring a proactive approach to quality assurance and quality systems
- Ensure safe and compliant processes for storage, distribution and marketing of medical devices and medicinal products in all MD&D Asia Pac Marketing Companies. Partner with CLS Operations and Quality partners to ensure appropriate roles and responsibilities are developed between local operating companies and CLS 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-001 and relevant Enterprise and Sector Quality Standards
- Implement applicable regulatory requirements (GMP, GDP, EN ISO 13485, MDD 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
- Ensure compliant Design Control quality systems are implemented at Asia-Pacific Innovation Center that are linked to Global Franchise MD&D R&D processes. Connect with Global R&D Quality partners to ensure appropriate levels of technical expertise and review are in place within Asia-Pacific R&D sites.
- Ensure engagement of commercial and cross-functional partners through the Management Review and Escalation process to ensure appropriate resources and support are provided to execute required quality system elements in a robust manner
- Work with Regulatory Affairs and the Enterprise Regulatory Outreach (ERO) activities to ensure timely gathering and assessment of new/revised regulatory requirements (regional+local)
- Ensure audit readiness for successful Health Authority and other regulatory body audits/inspections and associated interaction and communication
- 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)
- Collaborate with Regulatory Affairs to obtain and maintain needed registrations and licenses for the distribution of medical devices and medicinal products
- 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&D Market 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.
- Oversee the management of Asia Pac 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 PE programs to drive organization capability building
- Ensure compliance to all applicable quality standards and regulatory requirements (specifically ISO 13485)
- Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools. Presents case studies and metrics to Regional Leadership.
- 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.
Strategy & Planning
- Develop a common vision and strategy of/for Quality and Process Improvement
- Ensure an Enterprise mindset within the Asia-Pacific MD&D Quality organization by championing partnering and sharing with Cross-Sector and CLS Quality colleagues
- Entrench a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of PE to drive business results
- Partner with the Asia-Pacific Strategic Business Systems group to develop and implement quality strategies that support innovative new business and commercial strategies
- 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 Asia-Pacific 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 CLS Quality partners to ensure a cohesive Asia-Pacific Quality Talent Strategy.
- Develop appropriate strategic and process performance measures/targets
New Business Development & Relationship Management
- Oversee the management of the Quality aspects of Due Diligence for NBD within Asia Pac, ensuring local franchise Quality teams are consulted and involved where necessary/ appropriate
- Develop Emerging Market Quality talent pool and ensure capabilities are developed to become self-sufficient in the necessary aspects of Quality Due Diligence
- Conduct pre- and post-reviews of Quality DD process for each deal and ensure decisions are arrived at without external/internal commercial pressures affecting outcome of Quality Due Diligence decision-making process
- Partner with the Quality Community, Business Leaders, PE Leaders, Process Owners & Project Teams
Qualifications
Qualifications, Education, Experience
- Bachelors or Master's degree in Business, Biosciences or Engineering or equivalent field coupled with extensive and relevant business experience in Quality leadership roles.
- Process Excellence experience across diversified business areas with ISO13485 or equivalent quality standards programs.
- Relevant experience in the healthcare or pharmaceutical industry is essential along with 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.
Location
This position is preferred to be based in Singapore.
Disclaimer
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Compliance
Description
Senior Director, Quality, Regulatory Compliance
Medical Asia Pacific
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 consumer, pharmaceutical and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
General summary
This role is responsible to establish and lead Johnson & Johnson MD&D Asia Pac'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. In addition this role oversees the management and flawless execution of NBD quality due diligence with clear alignment to company strategic objectives and J&J corporate quality policies.
The scope of this role includes the MD&D Asia Pac Marketing companies across all umbrella and direct MD&D Franchises, The scope also includeds quality oversight of regional MD&D R&D Centers and NBD activity. Responsibilities may be altered at the discretion of the MD&D CQO and as determined by changing Asia Pac business needs.
Reports To: Vice President, Strategic Business Systems, J&J Medical Asia-Pacific
Dotted to: Vice President, MD&D Market Quality
Job responsibilities include:
Manage Quality System
- Lead the J&J MD&D Asia Pac Quality Community, ensuring a proactive approach to quality assurance and quality systems
- Ensure safe and compliant processes for storage, distribution and marketing of medical devices and medicinal products in all MD&D Asia Pac Marketing Companies. Partner with CLS Operations and Quality partners to ensure appropriate roles and responsibilities are developed between local operating companies and CLS 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-001 and relevant Enterprise and Sector Quality Standards
- Implement applicable regulatory requirements (GMP, GDP, EN ISO 13485, MDD 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
- Ensure compliant Design Control quality systems are implemented at Asia-Pacific Innovation Center that are linked to Global Franchise MD&D R&D processes. Connect with Global R&D Quality partners to ensure appropriate levels of technical expertise and review are in place within Asia-Pacific R&D sites.
- Ensure engagement of commercial and cross-functional partners through the Management Review and Escalation process to ensure appropriate resources and support are provided to execute required quality system elements in a robust manner
- Work with Regulatory Affairs and the Enterprise Regulatory Outreach (ERO) activities to ensure timely gathering and assessment of new/revised regulatory requirements (regional+local)
- Ensure audit readiness for successful Health Authority and other regulatory body audits/inspections and associated interaction and communication
- 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)
- Collaborate with Regulatory Affairs to obtain and maintain needed registrations and licenses for the distribution of medical devices and medicinal products
- 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&D Market 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.
- Oversee the management of Asia Pac 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 PE programs to drive organization capability building
- Ensure compliance to all applicable quality standards and regulatory requirements (specifically ISO 13485)
- Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools. Presents case studies and metrics to Regional Leadership.
- 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.
Strategy & Planning
- Develop a common vision and strategy of/for Quality and Process Improvement
- Ensure an Enterprise mindset within the Asia-Pacific MD&D Quality organization by championing partnering and sharing with Cross-Sector and CLS Quality colleagues
- Entrench a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of PE to drive business results
- Partner with the Asia-Pacific Strategic Business Systems group to develop and implement quality strategies that support innovative new business and commercial strategies
- 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 Asia-Pacific 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 CLS Quality partners to ensure a cohesive Asia-Pacific Quality Talent Strategy.
- Develop appropriate strategic and process performance measures/targets
New Business Development & Relationship Management
- Oversee the management of the Quality aspects of Due Diligence for NBD within Asia Pac, ensuring local franchise Quality teams are consulted and involved where necessary/ appropriate
- Develop Emerging Market Quality talent pool and ensure capabilities are developed to become self-sufficient in the necessary aspects of Quality Due Diligence
- Conduct pre- and post-reviews of Quality DD process for each deal and ensure decisions are arrived at without external/internal commercial pressures affecting outcome of Quality Due Diligence decision-making process
- Partner with the Quality Community, Business Leaders, PE Leaders, Process Owners & Project Teams
Qualifications
Qualifications, Education, Experience
- Bachelors or Master's degree in Business, Biosciences or Engineering or equivalent field coupled with extensive and relevant business experience in Quality leadership roles.
- Process Excellence experience across diversified business areas with ISO13485 or equivalent quality standards programs.
- Relevant experience in the healthcare or pharmaceutical industry is essential along with 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.
Location
This position is preferred to be based in Singapore.
Disclaimer
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Compliance
