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Overall Purpose of Job:

Leads the Commercial Quality & Compliance organization in MedTech for Surgery Business Unit and provide leadership & strategic direction to the Surgery CQ Team to establish, maintain and improve quality assurance programs for India and neighboring markets (Sri Lanka, Bangladesh, Bhutan, Maldives and Nepal). Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products, handling of products by Supply Chain / Deliver partners consistent with established standards by performing the duties personally or through subordinates.

The responsibility covers for Surgery Business Unit and EP (Electrophysiology) business as part of the Hosting Model under Project Optimize.

Key Responsibilities:

1)   Responsible for India overall Quality Management and daily Commercial Quality operations –

a)  Acts as Management Representative (MR) for JJMTI business.

b)  Works with regional commercial quality leadership teams to drive regional Q&C and India commercial strategies to support India business

c)  Establish effective local marketing company quality management systems that drives proactive quality, robust corrective action and preventive action (CAPA) and risk management processes.

d)  Ensures that performance and quality of products conform to established company and regulatory standards.

e) Manages the qualification and validation for all products and processes and quality control support activities.

f)   Ensure compliance to all quality standards and regulatory requirements, manage internal and external audits to validate compliance and identify opportunities for improvements.

g)  Drive quality performance and quality continuous improvements

2) Accountable on routine Commercial Quality Operations –

a)  Maintain quality management system and ensure compliance on every stage of the operations such as but not limited to :

i)  post market surveillance activities in complaint management, adverse event reporting

ii)  Conduct gap assessments and provide implementation action plan.

iii)  Deliver quality operation metrics and targets

iv)  Service & Repair QMS.

b)  Ensure timely new product innovation launches.

c)  Ensure oversight of quality and compliance at local distribution centers that receive, pick, pack, store, inspect, repack-relabel and deliver finished goods to Customers for Medical Devices India.

d)  Oversees supplier auditing and qualification for new or proposed suppliers.

3)  Represent the voice of the customers, patients and Quality & Compliance on all MD matters. Actively partner local authorities and industry associations to shape local regulations related to post market surveillance.

4)  Grow and develop team in leadership, technical and key current and future capabilities and competence to support business.

5)  Manage budget and right size quality organization.

6.) Any other tasks or responsibilities as assigned.


Educational Qualification:

Graduation or Postgraduation in Engineering or Pharma

Experience :

Mandatory:

10+ years of relevant post-qualification experience

People management experience of at least 3 years, inclusive of developing, mentoring, and coaching

Experience in the Pharmaceuticals, Healthcare and/or Medical Technology industries

Preferred:

ISO 13485 certification (Lead Auditor)

Travel: 20%

Required Skills:

Preferred Skills: