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Healthcare Businesswomen’s Association

Manufacturing Unit Head

Healthcare Businesswomen’s Association, Raleigh, North Carolina, United States

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Job Description Summary Lead the Manufacturing Unit team to manufacture and deliver high-quality and affordable pharmaceutical products on time, every time, safely and efficiently. Lead the manufacturing unit operational excellence based transformative journey to improve the performance, productivity, quality in order to ensure the site competitiveness.

Job Description Location Durham, NC

#LI-Onsite

This role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC and will eventually move to Morrisville, NC at a later date.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Main Activities

Develops and follows-up the medium and long-term strategy for department in connection with the site strategy in order to guarantee profitability and meets the needs of the site and the company, in accordance with the strategic vision of the site and Novartis Technical Operations (NTO)

Ensures overall financial and business performance, safety, quality, costs, supply and resource management (people, equipment, facilities, etc.) and represent this in the site leadership team

Ensure the efficient distribution of the Unit's resources (CAPEX, OPEX, expenses, FTEs).

Builds/sustains strong network in and outside the organization and with the Operations Centers

Change and Transformation Leadership

Develop and implement strategy within manufacturing unit aligned with NTO strategy

Oversee all site manufacturing operations

Be accountable for resource planning and allocation for manufacturing site and project execution

Ensure optimal collaboration and synergies among various functions and units to continuously improve internal processes and seamlessly fulfill business objectives

Responsible for implementation of and compliance to the principles and practices of Novartis manufacturing standards

Role model values

Be a learner, not a knower

Be clear, present and focused

Develop trusting and respectful relationships

Manage your energy and impact

Sets performance targets for the Manufacturing Unit in line with business objectives and develops long-term plan in line with global and site strategy

Engages and motivates the team and delivers strong results with an empowered team

Creates environment of trust, assures clarity and open two-way communication, and fosters a speak‑up mentality

Knowledge and Development of Talent and Pipeline

Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and manufacturing unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and site

Invest time in personally developing and coaching talents

Actively support and promote talent exchange for the benefit of the individuals and organization

Ensure the consistency between career development processes and the business strategy

Develop the organization in accordance with NTO principles

Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates

Ensure that associates are qualified for a GMP task prior to independent performance

Monitor overall training compliance for in-scope associates

Identify and maintain a list of subject matter experts for in-scope areas of expertise

Active Culture Building

Create a work environment that enables high employee engagement

Sponsor execution of culture plan (including HSE, Quality, OpEx (operational excellence), and Leadership aspects) for the manufacturing site, ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey

Role model the culture aspiration of being Curious, Inspired and Un-bossed

Quality and HSE

Guarantee the conformity of the manufacturing unit activities with regard to GMP and HSE rules, Novartis quality/safety policies, and the standards and quality/safety procedures

Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site

Ensure overall inspection readiness for area of responsibility.

Guarantee the effectiveness of the Business Continuity Plan

Be responsible for the implementation, compliance and governance of the practices explicitly defined in their role by the "Novartis Manufacturing Manual"

Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the Site Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on‑call management system.

Responsible for participating in initial training and retraining

Digital Curiosity

Explore the potential of data and technology to support transformation journey of the manufacturing site in-line with NTO strategy

Encourage others to learn about and leverage data and technology

Operational Excellence, continuous improvement and COGS competitiveness

Sponsor continuous improvement initiatives via Manufacturing Science & Technology, Lean manufacturing, 6 Sigma to increase the site performance against current and future business objectives

Lead the LEAN philosophy of innovation / Quality / productivity (LEAN IQP) within the Unit and guarantees the continuous improvement of the whole process.

Define the operational improvement policy/strategy and establish the portfolio of continuous improvement projects and prioritize improvement actions based on available resources

Ensure the progress and sustainability of the results obtained

Manage module-related financial and operational drivers underpinning superior performance

Sponsor OpEx initiatives in the manufacturing site

Key Performance Indicators

Achieve plant KPIs

Service level (no stock-out / no delay in production)

Costs control and competitiveness

Number of customer complaint on quality, cost of poor quality

success rate of HAs inspections

Right first time (Right First Time (RFT))

Number of overdue compliance activity, effective CAPAs

Launch performance on time

P&O: Satisfaction survey, execution of talent and development plans, technical training program in place and executed, training data, attracting and retaining talent, succession plan for Manufacturing unit in place and robust

HSE: Work accident rate, presence of the manager, success rate of inspections, reduction of waste, efficiency

OpEx: Productivity Improvements

Relevant Experience

Minimum 10 years’ experience in pharmaceutical or life science industry in a GMP environment, preferably in commercial manufacturing

Min. 5 years’ experience in operations management and execution

Proven experience driving quality and compliance in an organization

Education & Qualifications

Bachelor degree in pharmacy, engineering, chemistry, biology or related (higher degree preferred) or completed vocational training with equivalent job experience

Qualifications in Lean Management, Operational Excellence certificate or comparable advantageous

Languages Fluent in English and proficient in site local language

Competencies

Excellent oral, written and presentational skills

Business mindset, stakeholder engagement

Change management, knowledge of all people management and development processes

Objective setting and performance management, managing budgets, lean management

Strong negotiator, influencing and persuading, ability to build relationships at all levels of the organization

Adaptability, ability to work under pressure, collaborating across boundaries

Project management / Operational Excellence

Strong working knowledge of regulatory requirements across multiple health authorities

Novartis Compensation and Benefit Summary The salary for this position is expected to range between $160,300 and $297,700/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance‑based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US‑based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range $160,300.00 - $297,700.00

Skills Desired Assembly Language, Biotechnology, Business Networking, Change Control, Chemistry, Continual Improvement Process, Cost Reduction, General Hse Knowledge , Incentive Program, Knowledge Of Gmp, Leadership, Lean Manufacturing, Learning And Development, Manufacturing Process, Manufacturing Production, Operations, Productivity, Risk Management, Root Cause Analysis (RCA), Six Sigma, Technology Transfer

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