Manager – Quality

Biopharma Asia; Mumbai; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Johnson & Johnson in Mumbai is seeking a senior leader to head Commercial Quality & Compliance for the Surgery Business Unit across India and neighboring markets. You will lead the India quality organization, drive CAPA/risk management, and ensure regulatory compliance.

The role requires 10+ years in pharma/healthcare/medtech quality, people management experience, and ISO 13485 Lead Auditor certification. Travel up to 20% is expected.

Qualifications

• 10+ years of post-qualification experience in Quality/Regulatory roles.
• People management experience of at least 3 years, mentoring and coaching teams.
• Experience in Pharmaceuticals, Healthcare and/or Medical Technology industries.
• ISO 13485 certification (Lead Auditor) preferred.

Responsibilities

• Lead India's Quality Management and daily Commercial Quality operations.
• Act as Management Representative for JJMTI business.
• Drive regional Q&C and India commercial strategies.
• Establish effective local marketing company quality management systems; drive CAPA and risk management.
• Ensure compliance to quality standards and regulatory requirements; manage audits.
• Oversee qualification and validation for all products and processes; QC support.
• Drive quality performance and continuous improvements.
• Maintain QMS and oversee distribution-center quality controls.
• Oversee supplier auditing and qualification for new/proposed suppliers.
• Grow and develop the quality team; manage budget and headcount.
• Travel up to 20%.

Skills

Quality leadership

Leadership

CAPA management

Audit and compliance

Education

Graduation or Postgraduation in Engineering or Pharma

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

Mumbai, India

Job Description

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%