Product Quality Lead

Job Description

Job Description

Company Description

At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute.
If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

The Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle. The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products.

Please not this is a hybrid role that requires on-site presence in one of our offices (Morrisville, NC or San Diego, CA).

Key responsibilities:
Including, but not limited to the following

• Ensure end-to-end compliance for product manufacturing and life cycle management, from clinical phase the termination of the commercialization of the product (as applicable)
• Provide Quality inputs in submission dossiers
• Implement and maintain Quality Risk Assessment and KPIs
• Lead complex changes
• Coordinate product QA activities across markets (e.g. launch)
• Provide guidance on product quality aspects and support site transfers
• Participate in audits and inspections
• Design SOPs and contribute to operational development
• Contribute to input in Quality aspect of Due Diligence processes
• Advice / leads Complex quality issues and influence global solutions to ensure continuous drug supply to patients.
• Collaborates closely with the rest of the Quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levels
• Support recall
• Responsible for coordination / issuing and approval of the APQR
• Contribute to developing and streamlining own operations
• Lead & coordinate Quality aspect for integration of new acquisitions
• Cooperate with team members and contribute to a positive work environment

Qualifications

• High-level education in pharmaceutical, biotech, or life sciences
• At least 10 years of experience in pharmaceutical and biotech products under GMP
• Proven experience in Pharmaceutical Development Organization being able to transition development projects into future commercial set-up.
• Strong leadership skills with a proven track record with Health Authorities
• Deep understanding of GMP & GDP requirements and strategic planning
• Fluent in English with excellent communication and interpersonal skills

Additional Information

Compensation and Total Rewards at Sobi

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $125,000-$165,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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