Product Quality Lead

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, 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 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.

Benefits

Additional Information

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).

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