Quality Head
il y a 2 semaines
#1 Sandoz was the first pharmaceutical company to receive approval of a biosimilar in Europe, Japan, and the United States. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
- The Quality Head
- Ensures, in close collaboration with senior management, that a suitable and effective pharmaceutical quality system is in place to achieve the company’s quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company;
- Actively participates in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system; ensuring proactively compliance with GxP relevant regulations and Sandoz Quality Standards;
- Ensures that any identified gap or non-compliance process, which could lead to shortages, withdrawals, product approval delays and eventually negatively affect product availability for patients, financial performance and reputation of the company, is appropriately escalated and addressed via corrective and preventive actions;
- Supports business growth, advocate continuous improvement and drive standardization and efficiency gains through innovation and operational excellence projects.
- Leads with high integrity and build a diverse, effective and agile quality organization and effectively manage all people management related processes;
- The Quality Head can act as:
- Qualified Person for Sandoz nv (1472H) or back-up
- GDP Responsible Person for Sandoz nv as per guideline 2013/C343/01,
- Directive 2011/62/EU and Commission Delegated Regulation 2016/161 or back-up
Major Accountabilities:
- Successfully lead the Quality team, attract, develop and retain 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. Lead the implementation and execution of the talent management strategy for all key positions in conjunction with regional colleague(s). Inspire people with integrity and through role modelling and cultural behaviors to enable to quality organization to transform and perform;
- Lead a quality culture with high awareness on data integrity and close collaboration with country business partners and ensure a state-of-the-art country quality organization is in place to best support overall business strategy;
- Ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management;
- Act as a company key point of contact for Health Authority field alert and drug shortages providing a link between supplying sites and the Health Authorities;
- Ensure that the applicable Medical Device legislative requirements are implemented and maintained within the quality management system and that the Medical Devices are distributed in compliance with FAMHP “Guidance for Distributors of Medical Devices”;
- Ensure a formal process is in place for reviewing the pharmaceutical quality system periodically and conduct regular review and assessment of process performance and product quality, actively involving senior management;
- Lead the implementation of applicable quality standards and effective CAPA processes and ensure compliance with escalation processes in the country organization;
- Ensure that relevant SOPs are aligned to HA regulatory requirements;
- Deliver successful GxP regulatory inspections and internal audits of the country organization;
- Continuously engage in benchmarking with other industries, industry peers and actively engage across countries in building proactive relationships with Health Authorities.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- What you’ll bring to the role:
- University degree in life sciences (e.g. chemistry, pharmacy or other life sciences) - advanced degree desirable;
- Registration on the list of Qualified Persons as required per RD 14/12/2006;
- Strong knowledge of GMP/GDP legislative requirements and work experience in a quality organization.
- Fluency in English is essential.
- Country language desirable.
Additional experiences:
- Significant leadership experience and proven ability to manage teams and motivate associates of varying backgrounds across a dispersed and matrixed organization;
- While entrepreneurial and focused on result, ability to maintain the highest degree of integrity and to represent the company’s highest ethics, moral behavior and professionalism;
- Proven strong experiences with people and stakeholders’ management - ability to build trusting relationships with senior management and other business stakeholders;
- Demonstrated strong self-awarenes
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