Manager - Quality Systems - Johnson & Johnson - Singapore

Job description
GENERAL RESPONSIBLITIES
Manage Quality System
- Work with the Director QS and APAC Quality Community, ensuring a proactive approach to quality assurance and quality systems.
- Assist with the development of appropriate strategic and process performance measures/targets.
- Leverage knowledge from MD&D Quality Systems and J&J Quality & Compliance groups to transfer J&J proven quality tools and programs.
- Establish and maintain local relationships with partnering organisations. Lead regional teams and provide subject matter expertise to affiliates.

- Support adherence to J&J Quality Policy-1 in all APAC Local Operating Companies, ensuring standardisation and education across the countries.
- Operate as a key business partner for quality and process improvement, understand business requirements and execute quality programs to drive organisation capability building.
- Support compliance to all J&J Quality Policy and Technical Standards and regulatory requirements where applicable.
- Lead quality investigation and/or internal audits to assess conformance to specifications, company procedures, and overall compliance to regulations.
- Work with source operating companies to implement respective Quality System responsibilities and assure appropriate communication channels are created and maintained.
- Participate on Quality System initiatives to develop and deploy standardized systems across AP that meet regional needs and advance capability.
- Support engagement of Commercial Leadership to ensure recognition of their quality responsibilities and to provide robust Quality Systems in APAC.

Strategy & Planning

- Promote process improvement culture within the business. Implement process management practices, verify/validate project results.
- Embed QMS management principles in the organisation, supporting cross-functional process improvement teams and effectively completing improvement projects central to these efforts.
- Engage all company employees in these initiatives, through interactive project coaching/consulting and change management strategies.

Operational Management

- Participate in and support improvement and deployment projects and teams. Build quality improvement capabilities, provide training & deployment consultation.
- Train people in process improvement methodologies, techniques, tools, language etc.
- Educating and coaching leaders, champions, process owners and project teams about applying PE methods and tools to improve processes and improve business results.

Relationship Management

- Partner with the Quality Community, Business Leaders, Process Owners and Project Teams.
- Work with external business partners and regulators to build capability and ensure compliance to quality standards.

SPECIFIC COMPETENCIES:

Distribution and Transportation Processes

- The ability to manage and ensure compliance of all distribution and transportation processes to relevant J&J policies and standards and Good Distribution Practices
- Demonstrates ability to communicate to non-compliant 3rd party vendors / suppliers regarding required corrective / preventative actions
- Demonstrates ability to develop and manage compliance specifications for all distribution and transportation processes.
- Demonstrates ability to develop and implement corrective / preventative action and mitigation plan recommendations to Q&C executives

Commercial Customer Quality

- The ability to manage and ensure compliance of all customer services, including customer complaint management, customer audits, product lifecycle impacts, etc.
- Demonstrates ability to communicate and manage noncompliant issues associated with 3rd party vendors
- Demonstrates ability to develop and manage compliance specifications for all customer services
- Demonstrates ability to develop and implement corrective / preventative action and mitigation plan recommendations to Q&C executives
- Demonstrates ability to operate with transparency and communicates risks to leadership

Local Market Acumen

- The ability to understand and adhere to key local market compliance standards to meet quality requirements and market needs, such as product licensing & authorizations, labeling regulations, repackaging / relabeling procedures, local market promotion / marketing compliance, etc.
- Demonstrates deep knowledge of compliance standards and current maturity of quality capabilities in key local markets through direct experience in market
- Demonstrates ability to make data-based recommendations on market viability for compliance to adopt new / reformulated products in key local markets
- Demonstrates high level of cross-cultural sensitivity, understanding of market product needs from consumer / affordability perspectives, including local market promotion / marketing compliance

Qualifications

QUALIFICATIONS:

- Bachelors or Master’s degree in Business, Biosciences or Engineering or equivalent field
- Relevant experience in the healthcare, medical device or pharmaceutical industries
- Quality & Compliance professional with at least 6 years of relevant experience
- At least 5 years in Quality leadership roles
- Experience with project management methodologies
- Proven track record of leading or coaching teams to achieve significant quality and process improvements
- Proven experience with ISO13485 or equivalent quality standards program.
- Ability to identify improvement opportunities.
- Excellent influencing and interpersonal skills.
- Ability to influence and interact at multiple levels of the organization.
- Ability to manage multiple priorities and deliver excellent results.
- Strong leadership skills.
- Excellent written and verbal communications skills.

DESIRABLES

- 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.

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