Manager - Quality

Johnson & Johnson Innovation; Mumbai; On-site; INR 4,500,000 - 6,500,000; Full time

Job summary

Johnson & Johnson seeks a senior Quality leader to drive Commercial Quality & Compliance for Surgery and EP businesses in India. You will lead the India CQ team, establish QA programs, and ensure CAPA, risk management and regulatory compliance across local operations and partners.

You will collaborate with regional teams, drive audits and supplier qualifications, and mentor a growing team while managing budget and travel up to 20% of the time.

Qualifications

• 10+ years of post-qualification experience in pharma/healthcare/medtech.
• People management experience of at least 3 years.
• Experience in Pharmaceuticals, Healthcare and/or Medical Technology industries.
• ISO 13485 certification preferred (Lead Auditor).

Responsibilities

• Lead the Commercial Quality & Compliance organization for Surgery and EP in India.
• Establish, maintain and improve QA programs, CAPA and risk management.
• Act as Management Representative for JJMTI business and drive regional strategies.
• Oversee audits, regulatory compliance, vendor qualification and supplier audits.
• Grow and develop the quality team and manage budget.

Skills

Leadership

Quality Management

People Management

Regulatory Compliance

Education

ISO 13485 Lead Auditor Certification

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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%