Product Quality Lead

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

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

• 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

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,…