Job Title Head Middle East

Description

363743BR

QA Head, Middle East



Sandoz is commited to helping millions of patients access biologic medicines sustainably in areas including oncology. With a strong portfolio of eight marketed biosimilars and a further 15+ in various stages of development, Sandoz has an unparalleled heritage and extensive expertise in the development, manufacturing and delivery of biosimilar medicines to patients and healthcare community.

Your responsibilities include, but are not limited to:

1.Lead the development of a consistent Quality Culture with high awareness on data integrity and close collaboration with GLS Country business partners and ensure a state-of-the-art Country Quality Organization is in place to best support overall business strategy.
2.Establish effective Quality oversight and ensure compliant GxP processes are implemented in the GLS cluster (namely for product availability in compliance with Marketing Authorization, effective change control management, effective complaint and incident management, effective risk assessment, effective Quality oversight for clinical studies and pharmacovigilance processes).
3.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.
4.Establish regular review and assessment of KQIs at the GLS Quality Committee and Executive Committees, ensuring close follow-up, control and compliance.
5.Ensure adequate Escalation across the Cluster organization and support effective and timely resolution of any GxP incident.
6.Prevent any potential compliance gaps and risks and ensure CAPAs will be ad-dressed.
7.Collaborate and work in good intelligence with the Hubs/ CoEs (like Export Market hub, QMS hub, training CoE...) to ensure Compliance and efficiency.
8.Deliver successful GxP regulatory inspections and internal audits of the GLS Organization.
9.Ensure that proper Quality oversight is implemented within the Cluster for 3rd parties/vendors/outsourced activities.
10.Ensure timely delivery of all quality services, and ensure all aspects of team activities comply with cGxP, legal, regulatory requirements and Novartis Quali-ty Manual and Policies.
11.Ensure that processes are in place to communicate any country specific requirements to both Region (external engagement) and headquarter level for all for GxP areas.
12.Ensure remediation activities all existing gaps, to ensure ongoing compliance.
13.Identify opportunities for continuous improvement identified and the punctual implementation of the annual Quality Plan implemented at Country level.
14.Attract and develop talents in the local Quality department supporting a diverse and inclusive culture. Ensure robust performance management to optimize productivity across the team.
15.Ensure appropriate Quality budget\'s management across in compliance with Company target, identifying Risks and Opportunities.

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

Education (minimum/desirable):
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

Languages:
Fluency in English and local language (oral and written), additional language(s) a plus.

Experience/Professional requirement: > 12 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.

Technical Knowledge/ Competencies/Experiences Expert understanding of GxP regulations from major Health Authorities
Prior experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities.
Prior experience in Regulatory submissions and registration
Prior experience in Product Lifecycle and product portfolio management
Leadership Behaviors/ Competencies 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.
Demonstrated ability to develop and communicate a vision for an organization and motivate others to follow.
Demonstrated 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.
Demonstrated track-record of operational leadership across multiple sites in the Quality function
Extensive track record of successful cross-divisional/cross-functional work with complex and multidisciplinary teams
Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude.
Proven self-starter with experience in initiating and delivering high impact projects and processes across a geographically and functionally diverse teams. Self-motivated with a high degree of ownership and accountability for results.
Outstanding facilitation skills for bridging between scientific and business stakeholders, and for managing effective and successful international and cross-divisional collaborations.
Demonstrated strength in applying strategic thinking, scenario evaluation and contingency planning.
Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.
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.
Demonstrated track record of attracting and developing talent. Actively coaches and mentors associate at all levels and provides development opportunities.
Demonstrated track-record of creating an inclusive, high performing culture which values and rewards the SANDOZ Values and Behaviors

Korn Ferry Competency Model:
Business Insight

, Courage
, Decision Quality

, Organizational Savvy, Strategic Mindset, Plans and Aligns, Interpersonal Savvy, Values Differences, Manages Ambiguity, Builds Effective Teams

Competency that differentiates High Performer

Division

SANDOZ

Business Unit

Commercial OPS SIR SZ

Country

Utd.Arab Emir.

Work Location

Dubai

Company/Legal Entity

NOV MIDDLE EAST FZA UAE

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No

QA Head, Middle East | Novartis

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