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 self- sufficient 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.
