Associate Director, Market Product Quality

Associate Director, Market Product Quality

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Associate Director, Market Product Quality

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Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our 'new' Sandoz!

As the Associate Director, Market Product Quality you will be responsible for the execution of processes related to the removal of products from the market in accordance with Sandoz Quality procedures and FDA regulations. Responsible for the execution of processes related to Health Authority reporting for Sandoz in accordance with Sandoz Quality procedures and US Regulations. Responsible for managing a compliant framework of GMP policies, directives, procedures and processes that support the Global Supply Chain Security program, including Serialization, Anti-Counterfeiting, and Product Authentication.

Your Additional Responsibilities Include, But Not Limited To

• Participate in Product Quality Escalation Meetings to facilitate the timely filing of Health Authority reports (i.e., FARs, BPDRs, Form 3911s)
• Provide guidance to colleagues concerning the Recall process and regulations.
• Coordinate and Provide information to FDA as necessary or requested regarding filed reports and recall investigations.
• Coordinate follow-up activities from Product Quality Escalation meetings as part of the event investigation as required.
• Facilitate and track the progress of Escalated events, Health Authority reports, and Recall audit checks as needed.
• Act as a liaison with partner entity recall coordinators and FDA.
• Maintain a shareable electronic database program which will be used for all Escalation, Health Authority reports, and Recall tracking for historical review.
• Monitor FDA communications for impact to Sandoz rules and policies.
• Supports the organization's compliance with DEA regulations, including required reporting, audit support and guidance / support to colleagues as needed.
• Execution and enforcement of Recall policies and procedures.
• Communicate Recall activities, actions, and requirements to internal stakeholders.
• Provide recall technical guidance to stakeholders during a Recall event.
• Coordinate Recall actions and activities with FDA as needed.
• Provide Quality and Compliance oversight and support for Sandoz, Inc. commercial product.
• Assist leadership to design, implement, and sustain a robust and compliant framework of GMP policies, directives, procedures, and processes that support the Global Supply Chain Security program, including Serialization, Anti-Counterfeiting, and Product Authentication.
• Assist with establishment of a sustainable strategy for the Global Supply Chain Security program.
• Maintain awareness of evolving Supply Chain Security regulations and trends and implement systems to address potential GMP compliance impact.
• Communicate effectively and build cooperative and supportive working relationships with Serialization, and Corporate Security team, sites, and cross-functional departments.
• Actively participate in pharmaceutical industry meetings, symposia, and workshops to establish industry relationships, best practices, and regulatory guidance as related to Supply Chain Security.
• Establish and maintain the Global Quality Supply Chain Security metrics.

Provide consistent and timely slides and metrics for KQIs on market product quality, compliance with the Quality Manual, and SOP / GOP implementation as needed (examples include Quality Management Review, town halls, etc.).

Support initiatives / activities that build, develop and educate the organization, both internally and externally

Requirements

A minimum of a bachelor's degree or higher in Pharmacy, Biochemistry, Chemistry, Biology,

Engineering or other related life science degree.

Minimum 5 Years' Experience In Pharmaceutical Recall Management.

7- 10 years' experience in pharmaceutical Quality & Compliance organization.

Experience developing and / or managing quality systems & processes.

Required expertise of FDA GxP regulations for pharmaceutical products and recall management.

In-depth knowledge of GMP requirements of Global Supply Chain Security Program, including Serialization, e-pedigree, Anti-Counterfeiting technology, and Product Authentication.

Position Location

This position will be located at the Princeton, NJ site and will not have the ability to be located remotely. Preference will be given to local candidates not requiring relocation.

Sandoz offers a generous employee benefits package that includes a competitive salary, health insurance coverage for medical, prescription drugs, dental and vision, a generous company match for retirement savings accounts, and generous paid time off. We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility in designing a schedule that works for our associates and the business.

The pay range for this position at commencement of employment is expected to be between $138,600 and $257,400 / year; however, while salary ranges are effective from 1 / 1 / 24 through 12 / 31 / 24, 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.

On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Sandoz EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Sandoz Reasonable Accommodations Statement

Sandoz, Inc. is 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 email to reasonable.accommodations@sandoz.com or call 1-609-422-4098 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Sandoz

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Product Management and Marketing

Industries

Pharmaceutical Manufacturing

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