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Medtech Commercial Quality Manager
3 weeks ago
Johnson & Johnson is recruiting for a CQ Manager, Quality System and Performance, MedTech CQ APAC, located within the APAC region.
The CQ Manager is a crucial part of the company's growth and success. This role is primarily responsible for supporting remotely the Commercial Quality function and driving business improvement initiatives in the fast-paced MedTech industry.
Main responsibilities:
This role will provide critical support for the establishment and maintenance of JJM APAC’s overall commercial quality management framework and quality system. This will be achieved through establishing preventive and corrective actions to mitigate potential or actual non-compliance risks, ensuring compliance to attain world-class operational/customer-focused capabilities, product safety and regulatory compliance.
This position reports to the Director, Quality Systems & Strategy, Commercial Quality, JJMT APAC.
Key Responsibilities:
- Work with the Director, Quality Systems and APAC’s Quality community, ensuring a proactive approach to quality assurance and quality systems.
- Assist with the development of appropriate strategic and process performance measures and targets.
- Work with the HMD, and J&J Quality & Compliance groups and the APAC Quality community, to ensure a proactive approach compliance to all quality standards and regulatory requirements, leveraging knowledge to transfer quality tools and programs.
- Lead quality initiatives through deployment of automated systems within J&J APAC region to improve compliance and efficiency for Quality System Management.
- Support engagement of Commercial Leadership to ensure recognition of their quality responsibilities and to provide robust Quality Systems in APAC.
- Demonstrate a high level of cross-cultural sensitivity, understanding of market product needs from consumer / affordability perspectives, including local market promotion / marketing compliance.
- Engage all company employees in quality initiatives, through interactive project mentoring/consulting and change management strategies.
- Lead quality investigations and internal audits of J&J APAC countries to assess risks and conformance to J&J requirements, specifications, commercial quality procedures, and overall compliance to regulations both internally and for J&J service suppliers.
- Lead and participate in initiatives to improve the compliance and management of the distribution of Loaner Sets.
- Lead and participate in initiatives to improve the compliance and management of local Repack/Relabel activities.
- Lead and participate in initiatives to improve the compliance and management of local Rework activities.
- Provide support in the deployment, use and training of electronic systems.
- Lead and participate in initiatives to utilize digital, data and analytics to improve efficiency and effectiveness of quality systems.
**Qualifications**:
**Qualifications**:
- Bachelors or master’s degree in science, Biosciences or Engineering or equivalent field.
Required:
- Relevant experience in the healthcare, medical device or pharmaceutical industries.
- Quality & Compliance professional with at least 6 years of meaningful experience.
- Experience with project management methodologies.
- Confirmed experience with ISO13485 or equivalent quality standards program.
- Excellent influencing and interpersonal skills.
- Ability to prioritize and deliver excellent results.
Preferred:
- Black belt or related experience in Six Sigma, Design Excellence, Lean Thinking, FPX project management process and Performance Dashboards.
- Change management models, methods and techniques.
- Process Excellence experience in diversified business areas.
- At least 5 years in Quality leadership roles.
Other:
- Occasional regional travel required
- No relocation is provided
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
