Product Quality Lead

Product Quality Lead

Role & Function

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.

Key Responsibilities

• Responsible for the E2E Compliance of one or several products, across the different manufacturing steps and the life cycle of the products starting from clinical phase until when applicable the termination of the commercialization of the product
• Responsible for the implementation and Maintenance of Quality Risk Assessment and KPIs for products
• Initiate, review and QA approve complex change cases.
• Ensures alignment of product changes and collaborates with key colleagues to develop bundling strategies that maintain global supply while improving product robustness as TT, NPI
• Coordinate product QA activities across markets (e.g. launch preparation within different hubs)
• Provides guidance and Quality input to the CQAs, specifications, comparability, and stability programs Supports site and method transfers
• 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
• Participates in audits internally / externally.
• Ensure Coordination of Inspection Readiness of the different CMOs involved in the manufacturing of products.
• Participate and collaborate in inspections from authorities or audits from other companies.
• Lead / QA representative of Product Governance boards
• Design governing and comprehensive SOPs, as well as review and approve GDP- and GMP-related SOPs
• Contribute to developing and streamlining own operations
• Lead & coordinate Quality aspect for Due Diligences processes
• Lead & coordinate Quality aspect for integration of new acquisition 

Qualifications

• High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• At least 10 years of experience within pharmaceutical and biotech products. Experience within QA operation, production, development and commercial environment
• Proven track record with FDA, EMEA and/or other Health Authorities
• Strong Proven leadership ability to manage challenging decisions in a logical and compliance manner
• Experience in strategic planning and organizational effectiveness
• Fluently spoken and written English

Personal Attributes

• Deep understanding of the GMP & GDP requirements
• Comfortable in a global and complex environment
• Interpersonal and leadership skills with ability to influence external Suppliers but also internally in a cross-functional environment to foster decisions and to propose solutions
• Great collaborative skills to develop strong relationships within Sobi but also with External Suppliers
• Result oriented
• Efficient communication with senior management, key stakeholders and strategic business partners
• Holistic business understanding 

This is a hybrid role that requires relocation to either Sobi in Switzerland (with 3 days in Basel office) or Sobi in Sweden (with 3 days in Stockholm office).

Application

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 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.