Hcbg Quality

**Job Description**:
**Location**:
Mainly based in Blacktown Manufacturing Site (60%) & required to travel to various local sites (North Ryde Head Office, Blacktown Manufacturing Site, Warehouses, Suppliers, Customers, etc.)

Key Objective of the Job:

- Lead Quality strategy alignment & Global HCBG and KCI QMS Integrations
- Implement Global QMS Deployment & Verification of Effectiveness, incl. CMP, ComplianceQuest, 3M Learn, PLM Enovia, etc.
- Lead day-to-day Quality Programs (CAPA Board, Internal Audit, Supplier Audit and External Audit & Management Review)
- Responsible for deploying HCBG Training Management, ensuring the availability of training records, personnel qualification records and job descriptions
- Facilitate and coach (SME) all functional and divisional Quality professionals

Position Description:
Lead the deployment of Global HCBG QMS and KCI QMS Integrations for internal teams:

- Manage cross functional operating activities to ensure systems procedures and tools are effectively implemented.
- Facilitate and coach (SME) all functional Quality professionals for the deployment of QMS within their assigned area of responsibility.
- Lead and coordinate the deployment of CMP, ComplianceQuest for all Health Care Business Group divisions, including KCI
- Conduct Verification of Effectiveness for CMRs deployed and adopted by KCI and HCBG divisions
- Collaborate closely with Global Process Owners & APAC Quality team to improve the maturity of QMS and/or to identify the gaps, required actions and address it accordingly

Actively participate in the future projects and continuous initiatives, such as:

- Lead the Quality Management Systems integration project with KCI for all modules, including integration of KCI ISO 9001 certification, Management Review, Complaint Management, Internal Audits, Supplier Quality Management, etc.
- Identify and consolidate various KCI Quality Documents to 3M procedures or migrating to 3M PLM Enovia platform

Lead and support the day-to-day various Quality & Compliance modules, such as but not limited to:

- Coordinate Risk Assessment and Scheduling/Program for Supplier Quality Assessments and Internal Audit Management
- Manage monthly CAPA Board Review for KCI, SPSD as well as HCBG, including follow up with all CAPA Owners to ensure completion in a timely fashion
- Overview the status and follow up with the Change Management owners/initiators to complete the required actions

Lead the external audits conducted by Certification bodies, Regulatory bodies as well as customers.
- Liaise and coordinate with all stakeholders for the external audits
- Follow up and address the audit findings with the process owners and keep the communication channel with the external bodies and customers.
- Conduct various educational and training sessions for all stakeholders in regards with Quality Compliance, including for Sales & Marketing, Technical and Regulatory Affairs

**Requirements**:
Someone with strong business acumen:

- Ability to comprehend business, quality processes and regulatory requirements
- Ability to make good judgements and seek transparency with manager to help making decisions
- Ability to prioritize and initiate works accordingly
- Sense of ownership and take pride of the works

Communication skills:

- Writing and oral (clear, concise and ability to articulate or present to various stake-holders both internal and external)
- Listening skills and willingness to learn and professionally grow with 3M
- Coordinate and lead works and tasks among peers (locally and globally) with resilient

Networking skills:

- Ability to build positive relationships, especially in current Covid-19 time (face-to-face or virtual social skills)
- Ability to collaborate with colleagues from different roles, functions and levels
- Keen to build reputation and credibility among her colleagues
- Stress management and emotion control

Adaptability to technology, various systems and software:

- SAP, Lotus Notes
- PLM Enovia
- 3M Learn
- Excel and basic formulas (e.g., Pivot tables, filtering, graphs, flowcharts)
- PowerPoint and basic formatting and presentation skills

Qualification:

- Tertiary degree in Science, Engineering or related fields
- Experience and strong knowledge of quality and regulatory compliance for pharmaceutical and medical device industry
- 5 to 8 years’ experience in Quality Management Systems within a regulated environment
- Certified QMS auditor or lead auditor with excellent attention to detail
- Strong computer skills in analytical and statistical software.
- Demonstrated ability to implement change in an organization
- Demonstrated ability to continue self education.
- Expected to have comprehensive and detailed knowledge of the regulatory requirements and understanding of therapeutic goods.

Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. You have flexi