Job Description Summary

In general, this position is responsible to focus on Post Market Quality ,Supplier Management & Internal Auditor initiating proactive measures by partnering with business and other stake holders to ensure Post Market Surveillance actively is performed and timely reporting to regulators. Supplier Management Process is followed in line to BD policies and procedures. Plan and perform Internal audit and related activities.. End to end execution of Field Safety Notifications as well as timely reporting of Adverse event to regulatory authorities.

Being Quality Business Partner if is the responsibility of the Quality Business Partner to proactively partner with their local Business and Functional counterparts to ensure the compliance requirements of India/SA businesses are met.

Job Description

Job Description

Job Title : Deputy Manager Post Market Quality , Supplier Management ,

Internal Auditor

Department : Quality Assurance

Job Location : Gurgaon, India

Job Grade : JG3

Report to : Associate Director Quality India / South Asia

Subordinate : Nil

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit www.bd.com .

POSITION SUMMARY

In general, this position is responsible to focus on Post Market Quality ,Supplier Management & Internal Auditor initiating proactive measures by partnering with business and other stake holders to ensure Post Market Surveillance actively is performed and timely reporting to regulators. Supplier Management Process is followed in line to BD policies and procedures. Plan and perform Internal audit and related activities.. End to end execution of Field Safety Notifications as well as timely reporting of Adverse event to regulatory authorities.

Being Quality Business Partner if is the responsibility of the Quality Business Partner to proactively partner with their local Business and Functional counterparts to ensure the compliance requirements of India/SA businesses are met.

KEY RESPONSIBILITIES

Be the point of contact for department for Quality compliance management.

Develop professional relationships with India Central and state FDA and other relevant government / non-government entities.

Manage activities involving post market compliance to government departments like FDA, as well as other regulatory bodies as required.

Manage all relevant Field Actions, including all negotiations with regulatory bodies and the local Business;

Manage all relevant Adverse Event notifications, including all negotiations with regulatory bodies and the local Business within the time frames and guidelines specified

Maintain necessary quality and compliance records.

Maintain and develop relationships with key stake holders as well as external customers.

In conjunction with the Sales & Marketing team provide timely information for the preparation of tender submissions and quotations for customers.

Undertake and/or support project work as requested by India Quality Head/ Country management.

Conduct investigation and lead CAPA implementation in case of any product issue occurred during distribution chain of BD product.

Cross train in, and perform, other quality assurance support activities as required, such as Complaints Processing.

Support Quality Procedures and Policies as outlined in the Company’s Quality Manual. Including support for internal QA and corporate audits of the system.

Adhere to the requirements of the Quality Management System as maintained by BD India.

Perform Quality operation task in SAP ( ERP System)

Being a responsible Pharmacovigilance person for drug products ensure all the activities are performed to comply to local regulation and BD internal policies and procedures.

POSITION REQUIREMENTS

Education:

Graduate /Master’s Degree in Science/Engineering or Quality

Relevant Experience:

1. Minimum 17 -19 years relevant quality assurance/regulatory compliance experience in the medical device/healthcare industry.

2. Relevant experience in quality systems for complaint management, supply chain/warehouse, failure investigation, corrective & preventive action, and document & quality records management.

Manufacturing experience preferred in medical device. Experience in interaction with FDA officials will be an advantage Experience in working with cross functional team Experience in performing internal and supplier audits

Job Competency Requirements:

Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to ISO 13485. Strategic Thinker/Change Agent: High energy, accountable and forward-looking; able to see larger business picture. Persuasive individual with the ability to work at all levels to educate and gain buy-in for Quality programs and initiatives; track record of creating a positive imprint on an evolving business; Effective Trusted Communicator, demonstrated ability to effectively educate and influence other stakeholders of the Quality System and compliance, encouraging ownership of quality vision and strategies. Problem Solver, a practical as well as analytical thinker, able to identify and diagnose problems and craft realizable solutions. he/she must also be able to successfully establish objectives, manage people and projects, both directly and through influence and measure results to ensure accountability. Must be comfortable and able to operate within a matrix organization that thrives on team work and consensus building. Good understanding of strategic thinking and knowledgeable in communication with regulators and Govt agencies. Excellent communication skills. Good knowledge of IT systems i.e. knowledge of using quality applications in ERP systems and other applications.

Living the Values

Demonstrate the behaviors that are the foundation for becoming a great Company; great performance, great contribution, great place to work:

• We do what is right

• We take personal responsibility

• We anticipate and address the challenges of patients and customers globally

• We innovate and improve continuously

• We respect, collaborate, challenge and care about each other

Leadership Competencies

Process Effectiveness – Understands results that must be obtained and establishes efficient plans for self and/or others to achieve them; alert to opportunities to improve existing processes for accomplishing work and pursues them.

• Good at figuring out the processes necessary to get things done;

• Knows how to organize people and activities;

• Understands how to separate and combine tasks into efficient work flow;

• Knows what to measure and how to measure it;

• Can see opportunities for synergy and integration where others can’t;

• Can simplify complex processes; gets more out of fewer resources.

Action Oriented – Is agile and timely in making things happen.

• Demonstrates willingness and commitment to work hard;

• Not fearful of acting with a minimum of planning;

• Seizes more opportunities than others

• Takes action when needed.

Drive for Results – Consistently strives to achieve challenging goals and objectives whether individually or through others.

• Can be counted on to exceed goals successfully;

• Is constantly and consistently a performer who adds value;

• Very bottom-line oriented;

• Steadfastly pushes self and others for results

Required Behaviors

Promotes an Inclusive Work Environment – Respects and values the diversity among us and leverages our differences to enhance our performance and working environment.

Customer Focus – Is flexible and nimble in keeping up with customer needs; is on the cutting edge of defining their next level of expectations, and working to exceed them.

Continuous and Versatile Learning – Proactively builds knowledge and skills of self and others, to increase value/contribution to the Company and to ensure personal and professional growth.

Teamwork – Puts into practice values and behaviors that contribute to group effectiveness and performance, and the achievement of team objectives.

Think Differently, Act Differently & Constructively Challenge Status Quo

• Share expertise in a positive way

• Increase collaboration, more networking & building relationships with internal & external stakeholders

• Embrace change and seek continuous improvement

Sensing & Monitoring

• Proactively participate in local industry associations

• Advocate with regulators/agencies

Travel Frequency

0

<25%

√

25%-50%

50%-75%

75%

Primary Work Location

IND Gurgaon - Signature Towers B

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.