Alcon - Affiliate QA Head

As the global leader in eye care and second-largest division of Novartis, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs. We offer the broadest spectrum of surgical, pharmaceutical and vision care products to treat many eye diseases and conditions, including cataracts, glaucoma, age-related macular degeneration, retinal diseases, dry eye, eye infection and eye inflammation, ocular allergies, refractive errors, and other ocular health issues. Alcon is the eye care division of Novartis with global annual revenue of 10.5 Billion US$.

Alcon is an Equal Opportunity Employer. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, age, sexual orientation, marital status, disability, or any other legally protected status.

We have an opening for Affiliate QA Head for Global Corporate Quality department reporting to Head of QA - ASIA & Russia.

Role Purpose

To manage and lead all Quality Assurance activities at the affiliate, assuring that all corporate policies and local regulatory requirements are met by Alcon products and processes.

Role Context, Overview and Scope:

Alcon is building stronger QA systems in Asia. We have a unique 3PL distribution model for our products in India spanning 47 warehouses; we have 3rd party manufacturing operations as well. So far, QA focus was driven through other functions, thus limiting its impact. We are now in the process of setting up a new QA organization in the country and need a qualified individual to lead it. This individual will be part of the country leadership team and will be responsible to ensure that we are able to comply with all GXP systems and Novartis policies.

We are looking for someone who comes with strong functional grounding, has experience of building the function, influencing both upwards and downwards without direct authority relationships and is able to drive the QA agenda through the organization.

Major Accountabilities

- Develop, implement and maintain the local Quality Management System (QMS), also covering all necessary GXP- s, norms, regulations and standards related to the scope of the affiliate business.

- Ensure that Corporate Procedures and Standards are properly deployed in to the local QMS and managed according.

- Creation, implementation and maintenance of SOPs to ensure their implementation through training and inspection activities involving the business units and third parties.

- Audits: Prepare, conduct and report internal/ external audits.

- Ensure the implementation and enforcement of good practices for the affiliate and third parties contracted.

- Develop, support and/or participate in CAPA plans generated from these audits.

- Ensure Third Parties are properly qualified, monitored and processes are compliant with Alcon Quality requirements (warehouse, distribution, redress/relabeling, etc.).

- Guarantee that products are storage properly, respecting their label statements, also handled, distributed and transported under their requirements.

- Investigate, when necessary, customer complaints related to product quality.

- Ensure that products received are in compliance with Alcon and local regulatory requirements, stored, handled and distributed properly.

- Investigate quality issues and/or review results provided by other departments.

- Manage deviations and Change Control.

- Escalate potential issues to Corporate QA.

- Ensure that the Annual Quality Risk Assessment is performed properly and in time.

- Conduct training for quality compliance requirements as applicable and needed.

- Leverage and synergize with resources from other Novartis divisions.

- Gather, maintain and report KPI's for quality assurance in accordance with corporate QA guidelines.

- Staff, organize, train, lead and develop a Quality Assurance department capable of carrying out the above responsibilities.

Key Performance Indicators

- All applicable QMs/QDs from the Novartis Quality Manual are authorized / implemented / Closed (QM%).

- Relevant Key Quality Indicators are implemented, regularly reviewed and reported to local and Corpo-rate Management (Cockpit).

- Issues are adequately/timely escalated and CAPAs implemented.

- Proper and timely completion of the NVS Annual Quality Risk Assessment.

- Regulatory inspections are effectively prepared, managed and followed up (#Inspections).

- Internal and External audit outcomes (Panned vs Performed)

Ideal Background

Education: Minimum Required: BS Degree in Engineering or Scientific field

- Preferred Level: BS in scientific discipline + MBA

Skills:

- Fluent in English both in spoken and written.

- Computer literacy with standard software platforms

- Quality Assurance

- Quality Auditor

Key Competencies/Behaviours: - Results Driven

- Leadership

- Problem solving and analysis

- People and results oriented style

- Customer / Quality Focus

- Empowerment / Accountability

- Mutual Respect / Trust / Loyalty

- Integrity, responsive, high commitment

Experience:

- Minimum Required:

- 7 years experience in regulated Industry (Devices or Drugs) with GxP experience, 3rd party management and quality auditing.

- Knowledge of FDA- s, EU`s, GMP- s, ISO 13.485 and local regulatory standards (As applicable)

- Two (2) years of relevant experience as Quality Manager

- Experience leading people and teams.

- Knowledge of Pharmacovigilance regulations.

- Experience as Internal Auditor

- Preferred Level:

- 9+ years practical experience in regulated industry with solid experience of pharma and medical device requirements, including supplier management for large multinational company (ies).

- Solid experience leading people, project management and cross-functional associates.