Supplier Quality Manager (m/f/d)

About the role

Location: Barcelona, Spain #LI-Hybrid

We are seeking a Supplier Quality Manager to help us managing quality aspects and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
This role will work directly with the External Supply Quality Operations Team and reports to the External Supply Operations QA Lead.

Key Responsibilities:
Single Point of Contact for all quality related activities at the external supplier, as well as leading of external suppliers qualification process and quality risk assessments.
Ensures that a valid QA agreement is defined and in line with Novartis requirements.
Oversight of all production & testing activities ensures compliance with cGxP, incl. data integrity and eCompliance.
Management of major and critical quality issues (deviations, complaints, recalls, adverse events, counterfeit and product tampering, stability failures, special case scenarios etc.) according to the Quality Agreement and the Novartis Quality Manual.
Escalation of quality issues as per the Novartis escalation policy and initiation of market actions, if required.
Review and approval of production, QC, and Analytical Science & Technology (AS&T) records.
Assessment / review of quality trends, product performance trends and support of Operational Excellence improvement projects.
Cross-functional alignment with other functions within Novartis (e.g. Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.)
Collaboration with Supplier Relationship Manager to align on external supplier business strategies to ensure an efficient operation of the external supplier business as a whole - participation in the business review of external suppliers.
Participation in projects as defined and ensure that all aspects are implemented and followed up.
Role Requirements

Essential Requirements:
Project Management experience.
Operations Management experience, Operational Excellence.
Digital & Technology Savvy.
Leadership, communication, and presentation skills.
Fluent in English.
Desirable Requirements:
Degree in Pharmacy, Chemistry, Biology or similar
Batch release experience
Sound experience in product development, aseptic manufacturing, commercial manufacturing, or analytical experience.
We offer temporary employment.

You are kindly invited to submit your application in English language, including CV.

Why Novartis?
Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn morehere: https://www.novartis.com/about/strategy/people-and-culture

Youll receive:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Functional Area

Quality

Division

Operations

Business Unit

QUALITY

Employment Type

Temporary

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No
Novartis

Fecha de publicación: 28/10/2023