Product Quality Lead

vor 2 Wochen

Basel, Schweiz Swedish Orphan Biovitrum Vollzeit

**Product Quality Lead**

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

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 10years 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 HealthAuthorities
- 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 relationshipswithin Sobi but also with External Suppliers
- Result oriented
- Efficient communication with senior management, key stakeholders and strategic business partners
- Holistic business understanding

**Benefits**:

- Free drinks
- Work from home

Schedule:

- Monday to Friday

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Basel, BS: Reliably commute or planning to relocate before starting work (required)

Application Question(s):

- Do you have a valid working permit for Switzerland?

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