Job ID

9 out of 10 prescriptions here in the US are filled by generic drugs. Sandoz is one of the top developers and manufacturers of life changing generic medicines and Sandoz has the aspiration to be the Leading Generic and Biosimilar Company in the world with a purpose of pioneering access for patients. We are looking for curious, innovative, driven people to help us get new generic and biosimilar products into the market to improve access for patients. Maybe that’s you.

• Actively leads Sandoz US CQ support of the business through interface and collaboration with all levels of Global QA units and local business organizations required to support product acquisition/ licensing/ divestment deals and launches.
• Contributes efforts to support, manage and govern any Operational Excellence (OpEx) or special projects initiatives in line with the Global, Regional or Country Organizations.
• Responsible to ensure that commercial products for the US Market are released in full compliance with regulatory requirements, GxPs, internal policies and procedures and in accordance with the business needs. Actively support NCQ US through interface and collaboration with all levels of Global QA units and local business organizations.

Major Accountabilities: (Describe the principal outcomes of the role)
Business Development & Licensing, Launch, Divestment and Integration

• Provide QA support and oversight for acquired or in-licensed assets, Divestments, Private label deals and launches.
• Ensure that Sandoz’s Quality Management Systems and applicable GxP rules are embedded in acquired or in-licensed assets, Divestments, private label deals and launches.
• Ensure issues related to new business deals are escalated to Management.
• Support creation, maintenance or continuous improvement of related standards/procedures for acquired or in-licensed assets, Divestments, Private label deals and launches BD&L.

OPEX/PMO

• Support Country efforts to complete OpEx and local projects and ensure they are effectively managed locally, while maintaining compliance.
• Provide support in the implementation of regional and global OpEx programs, projects and initiatives at the local level as required.
• Provide support to complete the development of projects and monitoring plans to ensure successful completion within scope, time, quality parameters and fulfilment of financials targets in line with the business strategies and priorities.

Batch Release

• Responsible for direct oversight of batch release functions to ensure compliance to regulatory filing requirements and GxPs, as well as Novartis policies and procedures as they relate to commercial finished goods to the US Market.
• Drives procedural and process review changes where necessary in order to ensure consistent adherence to internal/external guidelines, policies, procedures, specifications and regulatory requirements.
• Ensure quality support for all launch activities.

General

• Provide oversight of the US stability and reference sample program as required.
• Review and approve documents requiring Quality approval, including deviations, stability and reference sample reports, and OOS/OOT investigations.
• Ensure issue escalation is executed and managed correctly, and that appropriate actions are taken and implemented in a timely and robust manner.
• Assist/support FDA readiness programs and inspections and internal/external audits.
• Maintain up-to-date knowledge with current industry trends, and Health Authority expectations.

The pay range for this position at commencement of employment is expected to be between $130,400. and $195,600. per year; however, while salary ranges are effective from 1/1/22 through 12/31/22, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

A minimum of a Bachelor's Degree or higher in Pharmacy, Biochemistry, Chemistry, Biology,
Engineering or other related life science degree experience provided

Languages:
English
Experience:

• Minimum of 10 years of experience in the pharmaceutical industry
• 5 years’ experience in Quality Assurance

Competencies: (Describe the knowledge, skills, and behaviors needed)

• Expert understanding of FDA GxP regulations and ability to apply them while evaluating business deal structure.
• 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 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.

Why Consider Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

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.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] 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.

COVID-19 Vaccine Policy: While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions.
#Orbit

SANDOZ

Quality STO

USA

Princeton, NJ

Sandoz Inc

Quality

Full Time

Regular

No