Director, Quality

vor 5 Monaten

Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

Reporting to the Executive Director, Quality, as functional manager and to the Vice President, GM Zug, as disciplinary manager. The Director, Quality, is responsible for creating, monitoring, and maintaining phase-appropriate levels of compliance at Kiniksa’s CDMOs, partners and internal operations related to selected clinical and commercial products.

This role is based in our Zug, Switzerland, office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

**Responsibilities **_(including, but not limited to)_**:

- Oversee all aspects of Quality related to the manufacturing and distribution of selected clinical stage products, as Qualified Person (FvP) according to Medicinal Products Licensing Ordinance, and according to Chapter 2.2 of EU GDP Guide 2013/C 343/01
- Deputize for the companies Qualified Person (FvP) for selected commercial products
- Manages relationships with Qualified Persons who fulfill the requirements of Article 49 of 2001/83/EC
- Responsible for the direct technical supervision of the related facilities
- Collaborate with partners in the development of Kiniksa’s products
- Host inspections from authorities and customer/partner audits
- Perform internal and external audits
- Oversee proper qualification of suppliers and service providers; approve Quality Agreements
- Approve master documents such as SOPs, test methods, specifications, and batch records for designated products
- Approve stability protocols and reports and if available stability master protocols and reports for designated products
- Ensure proper handling of CAPAs
- Approve critical and major deviations and ensure appropriate management of deviations
- Approve critical and major changes and ensure appropriate management of changes
- Ensure GDP with medicinal products and their quality, integrity and safety
- Ensure traceability of distributed product
- Determine the final disposition of returned, rejected, recalled or falsified products
- Decide on the release or rejection of batches independently of the company’s management.
- Authorized to give instructions in their area of activity
- Assure appropriate review and approval of manufacturing and control records
- Develop and maintain appropriate quality systems to support compliant and timely product release for clinical products and monitor performance to established targets
- Notify competent authorities of quality defects and (suspected) falsified products.
- Initiate, carry out and evaluate recalls and other risk-reducing actions; personally, directly supervise any risk-reducing action
- Approve Annual Reports and DSUR of Kiniksa for designated products.
- Ensure performance of Quality Management Review
- Evaluate and approve compliance documentation including regulatory filings for designated products
- Provide leadership, guidance, and direction to team and staff consistent with cGMP and GDP
- Develop Quality objectives and ensure progress and cross-functional completion; use judgment to develop solutions and drive risk analysis and mitigation strategies
- Embody Kiniksa’s cultural values and align actions with departmental goals and company culture

**Qualifications**:

- 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality, or an equivalent combination of training and experience
- Bachelors or Advanced degree in a scientific discipline
- Current status of Qualified Person (QP) or Responsible Person (FvP)
- Swiss German/German native speaking, fluent in English with excellent verbal and written communication skills
- Successful track record in managing external partners and batch certification to market
- Understanding of worldwide requirements of cGMP and quality systems
- In depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, global GMP/GDP standards, and Swiss MPLO 812.12.1
- Experience in working with teams in other geographies
- Experience interacting with regulatory health authorities at pre
- and post-approval inspections
- Established expertise and training in GxP systems
- Strong team player that has a customer service approach and is solution-oriented
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Strong commitment to compliance and ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 10%

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