Novartis zoekt een

Country Quality Head - QP/RP

Amsterdam, Netherlands

About the Role

Location: Netherlands, Amsterdam

If you are the person full of passion, energy, looking for innovative solutions for the patients and enjoying working in the TEAM of people sharing your inspiration and openness – this the position for YOU!

The purpose of the role is, through effective leadership, to
ensure all quality-relevant processes within the Dutch Country Organization are compliant and that non-compliance is appropriately addressed via corrective and preventive actions (CAPA) and/or escalation of issues.
Provide Quality oversight and governance to ensure proactive compliance with Novartis and Health Authority GxP requirements, and to meet business expectations.
Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation.


Your key responsibilities:
Your responsibilities include, but are not limited to:

•Lead the development of a cross-divisional Quality Culture with high awareness on data integrity and close collaboration with the Netherlands Country business partners and ensure a state of the art Country Quality Organization is in place to best support overall business strategy.
•Establish effective Quality oversight and ensure Quality Plan is implemented in the Dutch Country Organization (namely for commercial batch release in compliance with Marketing Authorization, effective change control management, effective complaint management, effective risk assessment, effective Quality oversight for clinical studies and pharmacovigilance processes).
•Act as the company key point of contact for Health Authority Field Alert and drug shortage reporting for pharmaceutical products and thereby provide a link between supplying sites and the agency.
•Establish regular review and assessment of KQIs at the Dutch Quality Committee and Executive Committees.
•Lead the implementation of applicable Quality Standards and effective CAPA processes and ensure compliance with escalation processes in the Dutch Country Organization.
•Ensure that relevant SOPs are aligned to HA regulatory requirements as well that products are released to the market in a timely manner and in compliance with the cGMP and MAHs.
•Deliver successful GxP regulatory inspections and internal audits of the Dutch Country Organization.
•Continuously engage in benchmarking with other industries, industry peers and actively engage across Countries in building proactive relationships with Health Authorities.
•Ensure timely delivery of all quality services, and ensure all aspects of team activities comply with cGMP, legal, regulatory requirements and Novartis Pharma corporate Quality Manual and Policies.
•Attract and develop talent in the organization supporting a diverse and inclusive culture. Ensure robust performance management to optimize productivity across the organization. Provide active mentoring and coaching of associates at all levels. Lead the implementation and execution of the talent management strategy for all key positions.

Diversity & Inclusion / EEO

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

Role Requirements

Essential Requirements :

•Bachelor’s Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g. Chemistry, Pharmacy or other Life Science). Advanced degree preferred.
•Fluency in English and local language (oral and written), additional language(s) a plus.
•Minimum 12 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
•Expert understanding of GxP regulations from major Health Authorities as well as prior experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities.
•Experience in Regulatory submissions and registration as well as experience in Product Lifecycle and product portfolio management.
•Strong organizational awareness and business acumen (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.

Desirable Requirements:

•Demonstrated ability to build trusting relationships with senior management and other business stakeholders. Demonstrated business acumen and ability to identify stakeholders needs and adapt communications style.
•Present ability to initiate and drive organizational change in complex matrix environment. Ability to lead others through change, effectively manage resistance, and ensure organizational engagement. Ability to influence and drive/facilitate change across the organization.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s 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 more here: https://www.novartis.com/about/strategy/people-and-culture


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 (link is external)

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