Director Quality Assurance

2 weeks ago

Penang, Malaysia Dexcom Full time

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

**Role Summary**:
As a member of the site leadership team this is an opportunity for an experienced impactful Quality Assurance Leader to significantly contribute to the scale up and ongoing operations of Dexcom facility in Penang Malaysia.

Key will be ramping and sustaining a Quality structure that supports all elements required for successful leadership and compliance of the facility and operation. Key areas of focus will be People, Manufacturing, Logistics and Distribution, Supply Base, and Sterilization workstreams.

**Essential Duties and Responsibilities**:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:

- Site Management Representative for the Site. Individual is primary interface during Notified body, FDA, or other regulatory body inspections.
- Ramp up of the Quality function in the manufacturing facility, providing leadership to this Quality team so as to ensure quality compliance across all functions;
- Hiring personnel for Operations Quality and compliance support
- Maintain robust compliance program ensuring compliance to local, national and international regulatory standards, company policies and procedures, and Corporate requirements
- Guiding all steps of the manufacturing realization program to ensure fully compliant to all expected guidelines and regulations pertaining to quality
- Engagement in supplier selection, ensuring development and qualification
- Ensuring successful facility validation including cleanroom(s), environmental controls, infrastructure systems, and equipment.
- Support on an ongoing basis;
- Strategic planning in the short and long-term from a technical (Quality and Regulatory) perspective
- Creation and achievement of site goals as aligned to the overall quality and regulatory strategy.
- Directs the Operations Quality Assurance Teams. Responsibilities include Quality Engineering, Document Control, CAPA, Non-Conforming Product, Microbiology, Calibration, Receiving Inspection and Lot Release. Defines priorities and delegates responsibilities.
- Establishes, reviews, and approves site and corporate procedures, as appropriate.
- Directs or conduct personnel training on domestic and international requirements and industry best practices. Ensures employee conformance to established requirements and proper training of staff
- Actively work in collaboration with other internal departments and external partners to ensure projects are delivered on time in compliance and in line with regulatory authority requirements.
- Continually seek opportunities for improvement while supporting a culture of knowledge sharing and learning
- Focus on people;
- recruitment, retention and motivation of the quality and regulatory team.
- Provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities.
- Support new product introduction and technology transfer and support registrations.
- Reporting on the effectiveness of the Quality Management System through regular reporting.
- Lead the organization through any required regulatory, and external audits.
- Management of budgets for the quality department and input to overall annual budget process.

**Required Qualifications**:

- Minimum of 15+ years of quality compliance experience (8 of which should be managing both direct reports and larger indirect organizations).

**Preferred Qualifications**:

- Sterility Assurance experience an advantage
- Experience in hosting regulatory inspections and/or conducting supplier audits
- Experience of greenfield start up/scale up an advantage
- Prior experience in high volume, clean room operations and monitoring

**Experience and Education Requirements**:

- Bachelor’s Degree in a relevant discipline required; Advanced Degree such as MBA, preferred
- Medical device industry experience in operations quality
- Experience in hosting regulatory inspections

**Travel Required**:

- 20%

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