Abbott - Senior Manager - Commercial Quality - India & SAARC

Senior Manager - Commercial Quality

Description:

- PURPOSE.

This position will provide Commercial Quality Leadership to India and SAARC markets in Abbott ID Rapid Diagnostics business.

- Responsibilities.

- Accountable for being Management representative with Responsibility & Authority forthe Quality and Regulatory requirements; ensuring compliance to Abbott Global.

- Quality/Regulatory Framework, Divisional Policies/ Procedures.

- Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs.

- Maintain QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.

- Must interface and represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.

- Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the Legal.

- Manufacturers and Tech Support Team.

- Proactively reviewing product complaints and address the trends in a timely manner.

- Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.

- Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.

- Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies).

- Ensuring implementation of effective CAPA program across operational site.

- Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).

- Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.

- Responsible for Budgetary Planning for Quality Operations.

- Evaluate the existing Quality Management System implemented in the country with the.

- Abbott QMS and Business Unit Quality Standards and Procedures and conduct gap analysis , develop a remediation plan and drive it to achieve highest level of compliance.

- Responsible for the Quality Control program for imported products that are distributed in the market.

- Has final decision making responsibility for product release.

- Has final decision making and reporting responsibilities for field corrective actions.

- Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken.

- Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.

- Continuously drive for compliance with Abbott quality standards and regulatory requirements.

- Responsible for management and satisfactory resolution of product issues in a timely manner.

- Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.

- Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.

- Responsible for coordination and management of site Quality metric tracking, trending and reporting activities.

- Assure metrics appropriately characterize the key performance indicators of the quality system.

- This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections.

- Coordinate and manage all commercial audits in conjunction with the Commercial office lead.

- Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements.

- Develop Commercial Quality team in the Cluster and the talent pool and ensure capabilities are in place to become selfsufficient in the necessary aspects of Quality.

- Implement Talent Strategies to grow quality capabilities, provide development opportunities for key talent, and drive a global mindset within the cluster.

Other duties as assigned.

BASIC QUALIFICATIONS | EDUCATION:

- Bachelor Degree in Pharmacy/Science/Engineering.

- Must have been employed in the Medical Device/Pharmaceutical /In-Vitro Diagnostics/Healthcare industry for a minimum of 7 years.

- Minimum of 10 years of experience in Quality Assurance and /or Compliance in a regulated industry.

- Minimum of 3 years supervisory / managerial experience.

- Ability to effectively communicate in English.

Competencies:

- Strong leadership influence.

- Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.

- Strong ability to negotiate with stakeholders.

- Able to manage multiple priorities and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the.

commercial businesses.

- Superior attention to accuracy and details.

- Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully in order to build positive relationships and improve business results.

- Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate, regional, and local objectives.

- Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.

- Strong knowledge of relevant medical device industry regulations for quality systems and compliance.

- Ability to work in a highly matrixed and geographically diverse business environment.

- Ability to work effectively within a team in a fast-paced changing environment.

- Multitasks, prioritizes and meets deadlines in timely manner.

- Experience in conducting and handling audits and inspections.

- An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

- We provide reasonable accommodation to qualified individuals with disabilities.