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Assoc. Dir. Patient Safety QA Sandoz DWA

Employer
Novartis
Location
Princeton, New Jersey
Salary
Competitive
Closing date
Apr 6, 2023

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Job Description

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.
Quality/compliance oversight of the Patient Safety (PS) organization to ensure that processes are defined and executed as per regulatory requirements, including vendor oversight from a country perspective.
Major Accountabilities: (Describe the principal outcomes of the role)
• In Country QA point of contact for the Patient Safety organization. Works in close collaboration with Development PS Quality and other key stakeholder including vendors from a country perspective.
• Provides the quality presence and input/guidance about the key QMS pillars to the PS organization and its vendors. Ensures an end-to-end patient safety quality oversight is in place including ensuring a harmonized QMS model is being followed globally and in country.
• Provides framework for oversight of all country PS vendors, ensures the qualified status is maintained as per company and regulatory requirements, including quality agreements are in place, audits are conducted as per the required frequency and risk profile is kept up-to-date for the outsourced activities.
• Provides quality support and acts as QA in patient safety (PS) country audits and inspections, including but not limited to vendor audits, process audits, pharmacovigilance agreement audits.
• Collection and trending of vendor management metric (KQIs), conducts quality management reviews in collaboration with Development PS quality.
• Ensures a compliant and a harmonized procedural governance is maintained in PS.
• Conducts and/or supports risk assessment for audit strategies in collaboration with Development PS QA.
• Acts as quality support and QA approver for country PS related (including for the outsourced activities where required) topics within QA systems, such as but not limited to exception management records, audit & inspection corrective and preventive actions, procedures, change controls, escalations.
• Together with partners, discloses risks related to quality compliance and patient safety, ensures risk communication/ escalation and coordinates mitigation
• Supports and/or executes self-inspection/self-assessment plan for the country.
• Active member of the External Service Provider Governance Board.
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.

Diversity & Inclusion / EEO

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.

Minimum Requirements

Bachelors degree or equivalent experience required

Languages:
English
Experience:
Minimum 5+ years of experience within the pharmaceutical industry e.g. in Patent Safety and / or Quality Assurance
Competencies: (Describe the knowledge, skills, and behaviors needed)
• Experience with vendor management desired, project management and indirect leadership experience in matrix organization advantageous
• Profound knowledge of GxPs and regulatory guidelines regarding scope.
• Extensive on the job QA experience ability to work operationally and strategically
• Knowledgeable and experienced in delivering in a matrix organizational environment, good stakeholder management skills
• Curious, agile and performance driven mindset
• Collaborative cross functional team player with business results mindset
• Experienced in working in an intercultural environment
• Quality mind-set, always looking for improvement and best practice sharing
• Motivated by challenge and change
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. Please send accommodation requests to [email protected] .

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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