Quality Manager Combination Products

vor 7 Monaten

Basel, Schweiz Skillhubs Vollzeit

Our client is looking for a **Quality Manager**.

**The role**

In this pivotal role, you will be responsible for providing compliance oversight associated with **medical devices** and **combination product **development and manufacturing processes internally or at contract manufacturing organizations (CMOs). Performs quality assurance responsibilities for Design Controls, Risk Management, Human Factors, CMO/supplier qualification, and Quality Systems including Change Control, Deviations and CAPA’s. Supports the development of a compliant device related Quality Management System (QMS).
Acts as Quality Leader driving operational excellence specific GxP processes and procedures partnering with Quality and R&D as applicable. Provide Medical Device Quality service and guidance to various stakeholders. Execute strategies to control, and improve quality for development projects through design controls, partnering with and influencing stakeholders to successfully embed a strong Quality culture. Identify, evaluate, and drive the remediation of quality risks and quality issues in our portfolio.

**Responsibilities**
- Drive the development of procedures in relation to CP/MD to further develop our QMS
- Create, approve, and improve design controls documentation for all phases of development for clinical and commercial programs. Provides compliance oversight per FDA 21CFR Part4, 820.30, 50, and 100, ISO3485, and EU MDR 2017/745
- Review and/or approve risk management files (PHA, FMEAs, Plans and Reports) in accordance with internal SOP(s) and ISO14971.
- Provide quality engineering expertise promoting best practices in design controls, process controls, device CAPA, risk management, design change controls, statistical sampling, risks assessments and essential design requirements, and critical to quality attributes.
- Implement quality tools to conduct root cause identification, risk assessments, change controls, and/or CAPAs.
- Organize, prepare, or attend design reviews and audits of the design history files (DHF) through product lifecycles.
- Serve as Device Quality SME on product development and manufacturing, maintaining knowledge of industry standards and regulatory requirements to ensure compliance to streamlined approach (21CFR part 4) QMS and GMP for combination products.
- Build relationships with customers in cross-functional areas across the company to communicate and execute a quality strategy.
- Prepare, review, and negotiate quality agreements and vendor documents i.e., drawings, protocols, deviations, and change notices.
- Review and approve deviations; risk assessments, root cause analysis investigations, CAPAs, and change controls.
- Other duties/responsibilities as assigned

**Profile**
- Education: University degree (Diploma/ Master) in a scientific discipline/ life sciences,
- Chemical/Industrial/Biomedical Engineering required, advanced degree, e.g., Ph.D. preferred.
- 7+ years experience in the pharmaceutical industry in a Quality function with experience/knowledge with medical device and combination product /finished product manufacturing processes.
- Broad knowledge of the drug development and manufacturing process, including experiences in commercial quality. Inspection experience with direct interaction with Health Authority inspectors desirable.
- Strong leadership capabilities in a matrix organization. High ethical standards as well as acknowledged personal credibility, ability to gain trust within the organization, including senior management. Visible and credible advocate for compliance and quality concepts with excellent communication skills.
- Ability to exercise judgment leading by example and coaching others on quality fundamentals.
- Record of successfully supported device marketing authorizations within the pharmaceutical industry. Ability to prioritize daily activities to meet customer needs and timelines in a fast-paced environment. Analytical and logical, is able to design and implement innovative, significant and complex business improvements.

**Job Types**: 100%, CDD

Ability to Commute:

- Basel, BS (Exigé)

Ability to Relocate:

- Basel, BS: Relocate before starting work (Exigé)

Work Location: In person

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