Head of Quality Apac/india
7 months ago
**Job Title**: Head of Quality APAC/India
**The Opportunity**
We have an opportunity for a Head of Quality APAC and India to join our team. In this role, you will be developing and leading the Quality team across the Zone that are responsible for Quality knowledge and culture, this is key in supporting Business Units and Zone partners in delivering to customers, oversight of compliance by Zone to local/ international requirements, Post Market activities, operational Quality, and driving continuous improvements as we continue to focus on.
**Your Role**
- Key Quality POC/Partner at APAC/India leadership Management teams.
- Representing Quality at local and extended Management Team forums. Develops and participates in strategic and tactical planning. Regularly interacts with executives and/or major stakeholders (e.g. Competent Authority/Regulators).
- Formulate and implement the Business’ long-range Quality and compliance policy.
- Actively promotes Quality awareness and culture in the Zone
- Deploy (a simplified) Quality system, and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting.
- Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
- Manages compliance with relevant key regulations across APAC & ISC and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
- Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling.
- Manages all inspections, audit and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.
- Manages the post market activities focusing on the product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
- Direct the Audit and CAPA Program for the organization.
- Drafts and manages the strategic improvement processes in the Region.
- Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
- Manage and develop the Quality organization
- To drive and grow business value, to set and achieve financial and strategic targets, and to participate in BG/Functions/PGI MT to ensure financially sound decision making.
- To own and manage the strategic & operational (Quality) planning process and performance management with the relevant organization and drive for the delivery of the committed results.
- To ensure appropriate business action & response to Quality issues, customer preferences, and external factors.
- To drive functional cost levels towards benchmark levels.
- Continue to maintain strategic relationships with Competent Authority /Regulators.
- Post Market surveillance Zone leadership (Vigilance reporting/Correction &Removal) Complaints /CFM management
**You're the right fit if**:
- Bachelor’s Degree (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline). Advanced degree preferred in the technical or clinical field.
- Minimum 10-15 years’ experience; at least 5 years’ experience in a senior leadership role in the medical device / pharmaceutical industry, highly regulated environment.
- Must have strong knowledge of ISO 13485, 9001, and 14971 (Risk management).
- Should have experience in setting up quality processes and in Quality Management Systems.
- Experience with managing product approval process in applicable markets and respective countries.
- In-depth knowledge of key requirements for Post Market Surveillance and experience interfacing with regulatory bodies /health ministries.
- Exercises supervision in terms of costs, methods, and staffing.
- Experience leading a team within an international matrix organization.
- Problem
- solving skills for complex regulatory, quality, and safety issues with demonstrated ability to balance business needs and regulatory perspective.
**About Philips**
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
- We’re living this commitment through our Reconciliation Action Plan and employee-led resource groups, and we encourage people from all backgrounds, including Aboriginal and Torres Strait Islander, Māori and Pacific Peoples, to apply. _
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