APAC CDQA Manager at Abbott

JOB DESCRIPTION:

Working at Abbott:

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
Our molecular division delivers best-in-class innovative testing solutions for people around the world, providing answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Position:

APAC Commercial and Distribution Quality Manager Location:

Delhi

Role Overview:

Our location in Abbott Molecular, New Delhi, APAC Area is hiring a APAC Commercial and Distribution Quality Manager. This role will be responsible for ensuring that the APAC commercial affiliates implement and maintain cost effective quality system solutions and remain in compliance with regulatory requirements, fulfilling the commitments of the region/division or corporate compliance plans. Throughout establishing and maintaining quality assurance programs, policies, processes, procedures and controls regarding:

• Quality Management System,
• Training related to the Quality System and GMP
• Change Controls, Exceptions and CAPA
• Quality Events Handling, Complaints, Product Actions, Significant events & Counterfeiting, Tampering, Diversion and Product Theft
• Supplier Management
• Quality Audit Program
• Material Control
• Risk Management
• Process and Gross Margin Improvement Projects

What You’ll Work On:

• Improves and maintains the quality system in the area of APAC Area.
• Ensures training and development for functional area is provided and documented.
• Prepare country organizations for division level, corporate and external quality system audits. Continuous consideration of process improvements and implementation.
• Responds to all Division/Area audit findings with proposed corrective and preventive actions within defined period, follows up on the implementation and effectiveness of actions taken.
• Perform and support the evaluation and maintenance for Supplier and Distributor management.
• Ensures compliance to local regulations.
• Provides quality oversight for the Singapore Distribution Center.
• Conceptualizes processes for labeling performed in the Singapore Distribution Center and ensures that the process is compliant and meets both Abbott and local regulatory compliance requirements.
• Provides oversight and advice for quality related issues for material control, supply chain and transportation.
• Responsible for the initial evaluation and documentation of spare part depots and refresh centers in APAC Area.
• CAPA SME within the Molecular Diagnostics area commercial affiliates, including One Abbott Commercial Affiliate workstream group representative.
• Act as coordinator between QA Des Plaines, local Molecular Diagnostics countries and Core Diagnostics Quality Representatives for complaint related tasks such as Field Action communication, Field Advisory Notices and related effectiveness checks and participate to the execution of required customer communications.
• Actively support country organizations, customers and distributors with appropriate answers in all quality related questions.
• Supporting Commercial Area Management Review and document the outcome.
• Identify and escalate the potential quality risks.
• support product- and cost improvements, new product launches and transfers.
• Implementation and maintenance of operating procedures relevant to Commercial and Distribution QA within APAC Area.
• Lead projects and continues improvement initiatives.
• Communicates and co-operates with co-workers, other departments and other
• Abbott divisions as needed and manages indirect report.

Required Qualifications:

• Education:

Bachelor's Degree in a related discipline.

• Experience:
• Minimum of 8-10 years’ experience in regulated industry.
• Excellent knowledge of the Quality System with understanding of the CAPA system and interrelated systems with an awareness of current processes and procedures as it relates to MDx Quality System and CAPA system.
• Must be able to influence, inspire, coach, and advise people on all Quality relevant aspects while complying with all policies and procedures of the Quality System impacting the commercial affiliates.
• Fluent oral and written English.
• Strong leadership, communication and organization skills.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

AMD Molecular

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)